Masthash

#FDA

LSDM
1 day ago

Singes morts à cause des implants Neuralink : Elon Musk aurait menti .

Alors que l’entreprise recherche des patients humains pour tester sa technologie, une enquête dévoile le sort peu enviable des animaux cobayes.

#Musk #Neuralink #FDA #Twitter

https://lsdm.live/modules/news/article.php?storyid=4453

https://lsdm.live/modules/news/article.php?storyid=4443

Nonilex
2 days ago

For decades, the Kochs have held deep antipathy to govt #regulation. When Charles #Koch’s brother David ran for VP on the #Libertarian Party ticket in 1980, the party platform called for abolishing the #EPA, the #DOE & the #FDA.

Every winter, the network holds its marquee #fundraising event in Coachella Valley in SoCal. Hundreds of #donors fly in to learn how their money is being spent & plan for the coming yr. Fmr staffers describe an emphasis on preventing #leaks that bordered on obsession.

Oden
2 days ago
Alan Kotok
2 days ago

A start-up biotechnology company says it received the okay for its investigational new drug application of an anti-viral drug to treat a whole class of seasonal flu strains.

https://sciencebusiness.technewslit.com/?p=45246

#News #Press #Science #Business #Biotechnology #Virus #InfluenzaA #FDA #SeasonalFlu #AntiViral #StartUp #Entrepreneurs #Preclinical #IND #ClinicalTrial #Regulations #Licensing

Zeitgeisty Aphorisms
2 days ago

#FDA will save us from Division but who will save us from #FDA?

cafepharma
3 days ago

AstraZeneca refused to pay full bonus to US remote worker, lawsuit claims -- Third time might be the charm for Alvotech's Humira biosimilar -- Roche scores—again—in hemophilia drug patent case against Takeda -- See more on our front page news http://bit.ly/w28kSd #astrazeneca #remotework #legal #employmentlaw #alovtech #humira #abbvie #fda #biosimilars #roche #genenetech #takeda #patents #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma

Poetry News
4 days ago

Eli Lilly launched a suit,
Against some US medical louts,
They tried to sell a pill,
Dubbed "Mounjaro" with a thrill,
'Twas not FDA approved, that's the doubt,
The spas, wellness centers and pharmacies,
Must answer for these wrong answers, please!

#elililly #medicalspas #weightloss #fda #poetry

https://www.reuters.com/legal/eli-lilly-sues-over-us-sales-bogus-mounjaro-weight-loss-2023-09-19/

Vanderbilt Biostatistics
4 days ago

Please join us next Wednesday (9.27) for a seminar by Dr. Jennifer Clark (lead mathematical statistician in the Office of Biostatistics at the FDA’s Center for Drug Evaluation and Research) discussing biostatistics at the FDA. The presentation will be held at 2525 West End Avenue (11th floor) and available online. Contact Cierra.Streeter[at]vumc.org for access. #biostatistics #FDA

https://biostat.app.vumc.org/wiki/Main/JenniferClark09272023

LSDM
4 days ago

Neuralink lance son premier essai clinique sur des humains.

L’expérience est baptisée PRIME pour Precise Robotically Implanted Brain-Computer Interface.

#IA #Neuralink #Musk #PRIME #FDA

https://lsdm.live/modules/news/article.php?storyid=4443

Biscuits & Gravy
4 days ago

Keep in mind, the #FDA, has approved #Neuralink for human trials.

...Animal 15 began to lose coordination and staff observed that she would shake uncontrollably when she saw lab workers. Her condition deteriorated for months until the staff finally euthanized her. A necropsy report indicates that she had bleeding in her brain and that the Neuralink implants left parts of her cerebral cortex “focally tattered.”...

https://www.wired.com/story/elon-musk-pcrm-neuralink-monkey-deaths/

#ShutMuskDown

Tech news from Canada
4 days ago

Ars Technica: Musk’s Neuralink seeks volunteers for brain implants—who’s in? https://arstechnica.com/?p=1969681 #Tech #arstechnica #IT #Technology #brain-computerinterface #clinicaltrial #quadriplegia #animalabuse #neuralink #ElonMusk #Science #Health #safety #ALS #fda

cafepharma
4 days ago

Amgen-Horizon merger clearance a setback to FTC's antitrust enforcement plans -- Genentech sees more potential in peptides, signs $1B biobucks deal with PeptiDream -- FDA rejects nasal spray for severe allergic reactions -- See more on our front page news http://bit.ly/w28kSd #amgen #ftc #antitrust #mergersandacquisitions #genentech #peptides #biobucks #fda #allergicreactions #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma

Jan R. Boehnke
6 days ago

In #ISOQOL-s most recent #QualityTALK, a team argues that while such a modular approach has advantages, it complicates the decision of choosing a PROM. The selection should take account of the overall trial objectives and context (e.g., see #ISOQOL, #SPIRITPRO, #SISAQOL) and involve all relevant stakeholders.
https://www.isoqol.org/implementing-the-fdas-draft-guidance-on-core-pros-in-cancer-trials-the-challenge-of-a-modular-approach/

Link to ISOQOL's perspective: https://www.isoqol.org/wp-content/uploads/2023/07/ISOQOL-R_HE-SIG-Comments-on-PFDD-Draft-Guidance-4_Final.pdf
and a commentary presenting the position:
https://link.springer.com/article/10.1007/s11136-023-03396-z

#FDA

Antonella T.
1 week ago

2/3

The bill will become law once it is signed by the governor of California, Gavin Newsom, having passed all the legislative stages. It is the first bill of its kind and once enacted, it marks the first time a US state has banned food additives that are permitted by the #FDA.

Proponents of the legislation hope other US states will follow suit by implementing similar bans, prompting a nationwide transition to safer alternatives.

Nonilex
1 week ago

“I will not stand by & let the #FDA & #CDC use healthy Floridians as guinea pigs for new #booster shots that have not been proven to be safe or effective,” said the “governor” in a written statement released after his “surgeon general” urged people under 65 not to get the booster. #DeSantis reiterated that position the next day on the talk show of Iowa-based commentator Steve Deace, saying fed #health authorities have been “corrupted by ideology.”

#Disinformation #PublicHealth #covid #Extremism

IT News
1 week ago

Toddler poisoned after eating deadly plant mislabeled as diet supplement - Enlarge / Yellow oleander. (credit: Getty | FlowerPhotos)

Last... - https://arstechnica.com/?p=1968912 #nuezdelaindiaseeds #supplements #indiaseeds #toxicology #weightloss #indianuts #newjersey #tejocote #science #health #poison #diet #fda

IT News
1 week ago

The spectacular downfall of a common, useless cold medicine - Enlarge / A box of Sudafed PE sinus pressure and pain medicine containi... - https://arstechnica.com/?p=1968612 #advisorycommittee #over-the-counter #allergymedicine #phenylephrine #coldmedicine #drugefficacy #efficacy #mucinex #sudafed #health #nyquil #merck #chpa #fda

Health Ranger
1 week ago

Brighteon Broadcast News, Sep 14, 2023 - Shocking science paper explains how 5G cell signals can unleash KILL VECTOR PAYLOADS in the human body

- #Ukraine destroys Russian submarine in cruise missile attack on Sevastopol dry dock
- #Russia likely to retaliate... is "Sea Breeze" naval op in the #BlackSea a BAIT provocation?
- NY Gov. Hochul tells everyone who took covid jabs, those won't work anymore, suckas!
- #FDA and #pharma are pushing a "whole new vaccine" with zero testing or clinical trials
- Bombshell story: Cell phone signals can remotely activate graphene oxide PAYLOADS in the human body
- 5G cell towers can, indeed, act as "kill vector" weapon systems
- #Vaccines can be used to inoculate people with graphene oxide containing toxic payloads
- Full interview with Jim Shepherd, founder of Berkey water company, on EPA abuse

https://www.brighteon.com/d002e94c-ddb2-4fe0-89af-ae1b28cbc102

Tarkloon
1 week ago

Florida Man sez don't get vaccinated...
Florida surgeon general rejects #FDA guidance, urges people under 65 not to get #Covid booster
https://www.politico.com/news/2023/09/13/florida-surgeon-general-fda-covid-booster-00115781

News18 India
1 week ago

💊 O FDA norte-americano concluiu que a fenilefrina é tão boa quanto um placebo para descongestão nasal quando uma pessoa está com gripe ou resfriado. Ou seja, não serve pra isso quando usada por via oral.

Desde os anos 2000 esse fármaco é usado nos EUA em remédios para gripe e representa uma indústria de US$ 1,8 bilhão por ano.

No Brasil, medicamentos como Cimegripe, Neolefrin e MultiGripe usam cloridrato de fenilefrina.

A Anvisa ainda não se pronunciou sobre o caso para produtos vendidos aqui.

:g1: https://g1.globo.com/saude/noticia/2023/09/12/fenilefrina-medicamento-para-congestao-nasal-nao-e-eficaz-diz-agencia-dos-eua.ghtml

#fenilefrina #remédio #FDA #Anvisa

Count RxBradula 🦇
2 weeks ago
OddOpinions5
2 weeks ago

#Covid #CDC #FDA #ACIP
can someone explain to me the hysteria in the last 3 weeks over ACIP advising new booster only for those over 65 or hi risk and actual CDC rec ?

Is it possible that Mastodon cherry picked what one person on ACIP said ???
no !!

thanks !!
https://www.cdc.gov/media/releases/2023/p0912-COVID-19-Vaccine.html

The new #COVID shots are expected to take aim at circulating strains, including the EG.5, or Eris, strain, which the #CDC said accounted for 21.5% of cases as of Sept. 2, as well as a newer variant, FL.1.5.1, dubbed Fornax, which accounted for 14.5% of U.S. infections.

The #FDA approved #mRNA shots from #Pfizer and #Moderna on Monday, and it's still reviewing a shot from Novavax that uses more traditional protein-based technology.

https://www.axios.com/2023/09/12/cdc-advisors-endorse-updated-covid-vaccines

2 weeks ago

Really interesting discussion on using #rstats for #fda submission from #NovoNordisk. Great to learn about their first submission with R code. https://www.youtube.com/live/t33dS17QHuA?si=s4u3p6QeC8HU-iHM

slyborg
2 weeks ago

https://www.fda.gov/media/171915/download

tl;dr FDA has concluded that phenylephedrine (Sudafed PE, etc.) is not better than placebo at relieving nasal congestion.

Which anyone that’s ever taken those for nasal congestion could have told the FDA.

#FDA

Bobby :verified_cool:
2 weeks ago

The truth has been exposed. #Meme #FDA

A meme of 2 astronauts in space, looking at earth.  Astronaut on the left says, "FDA says popular decongestant used in medicines are ineffective."  Astronaut on the right is holding a gun to the first astronaut and says "Always have been".
Donna Young
2 weeks ago

"Vaccination against #COVID19 remains the most important protection in avoiding hospitalization, long-term health complications & death. I encourage all Americans to stay up-to-date on their vaccines." - @POTUS Biden
https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/12/statement-from-president-biden-on-fda-and-cdc-actions-on-updated-covid-19-vaccines/ #SARSCoV2 #GetBoosted #FDA #CDC #ACIP💉😷💉

SubtleBlade ⚔️
2 weeks ago

Decongestant ingredient in popular products does not work, #FDA concludes

Advisory panel reviewed studies of #phenylephrine, an active ingredient in #Benadryl, #Mucinex, #Sudafed PE and #Tylenol
https://www.theguardian.com/us-news/2023/sep/12/decongestant-ingredient-does-not-work-fda-phenylephrine
#Health

Alan Kotok
2 weeks ago

A new company developing treatments for neurological and psychiatric diseases from aberrant immune system activity is raising $58 million in seed funds.

https://sciencebusiness.technewslit.com/?p=45199

#News #Press #Science #Business #Biotechnology #Finance #Autoimmune #Encephalitis #MentalHealth #Psychosis #SeedFunds #VentureCapital #Investment #Preclinical #FDA #OrphanDrug #RareDisease

Laffy
2 weeks ago

⚠️ “#FDA advisory panel declared an ingredient in widely used oral #decongestants doesn’t work, setting the stage for dozens of products to be removed from U.S. store shelves. 

At issue is phenylephrine, an almost-century-old ingredient in versions of Benadryl, Mucinex, Tylenol and other over-the-counter pills, syrups and liquids to clear up congested noses.”
- The Wall Street Journal https://apple.news/A0v6rsr0eQSi20SYLIdoRIg

IT News
2 weeks ago

Updated COVID boosters get green light from FDA ahead of CDC review - Enlarge / The Food and Drug Administration headquarters in White Oak, M... - https://arstechnica.com/?p=1967187 #pfizer/biontech #mrnavaccine #sars-cov-2 #boosters #covid-19 #fallshot #vaccines #science #moderna #novavax #omicron #health #pfizer #cdc #fda

R Consortium
2 weeks ago

📢 R Consortium Pilot 3 Milestone 📢

Big news! R Submissions Working Group successfully submitted the pilot 3 R-based package to FDA eCTD on August 28, 2023. This is the first public R-centric FDA submission!

🔗 Details: https://www.r-consortium.org/announcement/2023/09/11/first-publicly-available-r-based-submission-package-submitted-to-fda-pilot-3

#RStats #FDA #DataScience #opensource

OddOpinions5
2 weeks ago

cleanse your timeline: Block FDA and Vaccine Vaccines for 3 days, so you don't get 1000s of toots that are all identical

#covid #FDA #Vaccines #Moderna #Pfizer

Donna Young
2 weeks ago
Monica Di, PhD :verified:
2 weeks ago

The latest from the #FDA about mRNA COVID-19 #vaccines

-5y+ regardless of previous 💉 are eligible to receive a single dose of an updated #mRNA #COVID #vaccine at least 2mo since last dose
-6mo to 4y prev vaccinated can receive 1-2 updated 💉
-Unvaxxed 6m-4y can get 3 doses of updated 💉

https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating

Laffy
2 weeks ago

YES! 💉😷 “#FDA gave the green light to updated #Covid-19 #vaccine booster shots from #Moderna and #Pfizer/BioNTech. The updated vaccines are each approved for people 12 and older and are authorized under emergency use for individuals 6 months through 11 years old. As part of the FDA’s update, the original bivalent Moderna and Pfizer-BioNTech Covid-19 vaccines are no longer authorized for use in the US” 1/...

https://www.cnn.com/2023/09/11/health/fda-signs-off-on-updated-covid-19-vaccines

Jim Parsons
2 weeks ago

@jsonstein @harmonygritz

a) Tony the Tiger is lucky he's not a rug in Cap’n Crunch's ready room

b) how long until the #FDA classifies ‘Pumpkin Spice’ as a Schedule 1 Drug? Society really needs to get that stuff off the streets

;)

#TIL that there is a real product called "Not Fried Chicken ice cream," the slogan is "weaponized mouth joy," and it is being recalled for possible Listeria monocytogenes contamination: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/life-raft-treats-recalls-ice-cream-products-not-fried-chicken-and-life-peachy-due-possible-listeria #FDA #foodSafety

There's some clown at the #FDA saying the latest #COVID-19 booster is intended only for the immunocompromised and people over 75. Submit a comment to the #CDC today: We ALL need access to boosters. https://peoplescdc.substack.com/p/tell-the-cdc-all-ages-need-updated?utm_medium=web&fbclid=IwAR1qKJS3Pn2X-YaP4EdfDMv_hVpguINtCDSXaPIxLskRuVeKHx04ano56ew

Faraiwe
3 weeks ago

@US_FDA is about to authorize the #COVID variant (BA.2.86) booster shot, next week.

@CDCgov is pondering whether to RESTRICT booster to some ages, 75+ initially.

You CAN tell them NOT to have their head shoved up their ass, and allow EVERYONE to take it by voicing your opinion, here.

https://www.regulations.gov/document/CDC-2023-0060-0001

YES, it DOES make a difference. Enough people honk at them, they WILL do the right thing. And ONLY then will they do the right thing.
#FDA #CDC #COVID

Nutrition data sources: Thoughtful list of specific information on food: calories, etc
https://support.cronometer.com/hc/en-us/articles/360018239472-Data-Sources
#calories #database #dieting #nccdb #food #usda #fda #+

Cory Doctorow
3 weeks ago

This leaves liberals in the increasingly absurd position of defending the indefensible: insisting that the #FDA shouldn't be questioned despite its ghastly failures during the #opioid epidemic; claiming that the #VotingMachine companies whose defective products have been the source of increasingly urgent technical criticism are without flaw.

9/

Dr. Brad Rosenheim
3 weeks ago

Make it make sense. On one hand, when it comes to medications that chemically induce early term #abortions, we are not supposed to take them because the #FDA didn't test them enough. But on the other hand, we have this. We cannot bar doctors for prescribing #ivermectin for COVID because it was never tested on that virus at all.

https://mastodon.tucsonsentinel.com/@TucsonSentinel/111008107209947816

Screen shot of toot linked in my post.

@taco I really hope they'll be forced to...

BTW: They already got forced by the #FDA to put a sticker on them saying "This is not a diagnostic tool nor has it been approved for any medical use by the FDA!"

Bo Morgan
3 weeks ago

Open source artificial pancreas software has gotten FDA approval! And open source hardware solutions are coming!

https://www.nature.com/articles/d41586-023-02648-9

#opensource #fda #diabetes #t1d #foss #fosh

Pierre
3 weeks ago

So many recalls at Trader Joes since July!

broccoli soup (insects), almond cookies (rocks), falafel (rocks), crackers (metal), tamales (milk allergen)

#alergen #recall #traderjoes #falafel #tamales #soup #cookies #fda

@bicmay I don't do the NYT paywall, so this article is off limits. Having said that, the #FDA has a great place to check if #COVID19 rapid tests have extended expiration dates. Many have and still work.

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

Kathy E. Gill 🇺🇦
1 month ago

Covid-19 cases continue to climb.

As a result, the #FDA is reportedly planning to ok release of this year's updated vaccine for mid- instead of late-September. Yeah!

The #CDC Advisory Committee on Immunization Practices is meeting on Sept. 12.

However BA.2.86 (#Pirola) has 36 distinct mutations from last year’s XBB.1.5, the target of the upcoming #covid19 #vaccine.

LATimes
https://apple.news/AWVGk3Wv7TJS6j_cUtY1fPg

Paul Chambers
1 month ago

Frozen vegetables recalled for possible listeria contamination

The brands are Food Lion, Signature but mostly Kroger's.

See the complete list at the below FDA link.
#Recall #Health #Food #FoodRecall #Recalls #FDA

:fda: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/twin-city-foods-inc-recalls-frozen-super-sweet-corn-and-mixed-vegetables-because-possible-health

Kroger mixed vegetable frozen package
Food Lion mixed vegetables
Kroger Sweet Corn
Signature Sweet Corn
Laffy
1 month ago

⚠️ #FDA warns of possible contamination of Dr. Berne's, LightEyez eye drops - UPI.com

https://www.upi.com/Health_News/2023/08/23/eye-drops-contaminated-bacteria-fungus/1651692795181/

Mike Reader
1 month ago

CDC, pharmacies try to speed up Covid vaccine program for the uninsured

Biden health officials are attempting to finalize contracts that would allow pharmacies to offer a Covid jab to uninsured Americans as early as mid-September, when the government plans to make an updated version of the life-saving vaccine available to the broader public.

https://www.politico.com/news/2023/08/21/pharmacy-covid-vaccine-uninsured-00112147 #CVS #Walgreens #FDA #health #healthcare #Pfizer #BioNTech #Moderna #Novavax #Covid19 #coronavirus #MRNA #HHS #Insurance

Raymond Scott Pert
1 month ago

US approves consumption and sale of “cell-cultivated chicken” — MercoPress

>The U.S. Department of Agriculture is revolutionizing the meat industry, it has approved the sale of cell-cultured chicken in a landmark decision that clears the path for consumers to try it out themselves, the two startups that received the first approvals announced.
https://en.mercopress.com/2023/08/17/us-approves-consumption-and-sale-of-cell-cultivated-chicken #FrankenFood #US #FDA #labmeat



Proponents of cultured meat say it’s healthier and more environmentally friendly than traditional meat. Outside the U.S., only Singapore has cleared the sale of cell-cultured meat.

@SrRochardBunson since those #shortages ain't a problem of #production and #supply but #FDA being #cruel and #inhumane, this should be qualified as #torture by the state!

Brittany Trang
1 month ago

"It felt like the Hunger Games":

Between 6th birthdays that came too soon & insurance companies denying coverage, families scramble to get their 5 year-olds treated under Sarepta's narrow #FDA approval for #DMD

What a gut punch ending.

https://www.statnews.com/2023/08/16/duchenne-muscular-dystrophy-sarepta-elevidys-gene-therapy-eligible-boys/

#health #healthcare #biotech #genetherapy #insurance #duchenne #musculardystrophy #parenting #medicine

SLCW💥
1 month ago

While public #health officials are urging #Americans to stay up to date with #vaccinations, the #Wisconsin #Senator #RonJohnson and #FoxNews personality Maria #Bartiromo falsely refuted #vaccine efficacy and safety while wrongly stating that #ivermectin is an #FDA-approved treatment.

https://www.theguardian.com/commentisfree/2023/may/16/florida-ron-desantis-bigotry-doctors-gay-people

Mufasa
1 month ago

#FDA warns against use of certain #pregnancy, ovulation tests

The Food and Drug Administration has issued an urgent recall for a set of pregnancy and ovulation tests the agency said it can no longer guarantee are safe.

Manufacturer Universal Meditech has stopped supporting the tests, the FDA said, bringing their reliability and safety into question.

The company issued its own recall for remaining stock at distributors, but not for those already sold.

https://thehill.com/policy/healthcare/4149922-fda-warns-against-use-of-certain-pregnancy-ovulation-tests/

fuomag9
1 month ago

@glyph @MattBinder Does anyone know how we can report this to the #police or #FDA ?

From doing a simple OSINT search this looks really bad in terms of health safety...

IT News
2 months ago

New SARS-CoV-2 variant gains dominance in US amid mild summer COVID wave - Enlarge (credit: Getty | Thomas Trutschel)

For a fourth consec... - https://arstechnica.com/?p=1959483 #hospitalizations #testpositivity #seasonality #sars-cov-2 #subvariant #wastewater #covid-19 #pandemic #vaccines #omicron #health #deaths #summer #cdc #fda

Paul Chambers
2 months ago

FDA approves nonprofit's over-the-counter opioid overdose nasal spray used to reverse opioid overdose

RiVive, made by Harm Reduction Therapeutics, is the second #nonprescription #naloxone product the FDA has approved.

But unlike other opioid overdose products, the 3 milligram treatment will be available for free or low cost, and its sales will bring no profit to its manufacturer

#DrugOverDose #Health #FDA #Opioid #nonProfit #RiVive #NoProfit

🔗 https://www.wcpo.com/fda-approves-nonprofit-s-over-the-counter-opioid-overdose-nasal-spray

RiVive product box

Photo by: Harm Reduction Therapeutics
Alan Kotok
2 months ago

The U.S. Food and Drug Administration issued new regulatory guidance for clinical trials of medical devices designed to prevent or treat opioid use disorder.

https://sciencebusiness.technewslit.com/?p=45044

#News #Press #Science #Business #Regulations #FDA #MedicalDevice #Opioids #OpioidUseDisorder #Overdose #Fentanyl #Heroin #ClinicalTrials #Efficacy #FederalRegister

Alan Kotok
2 months ago

A treatment for HIV taken just once, using the genome-editing technology Crispr, is receiving fast-track designation from the U.S. Food and Drug Administration.

https://sciencebusiness.technewslit.com/?p=45011

#News #Press #Science #Business #HIV #AIDS #Infections #AntiretroviralTherapy #ImmuneSystem #GenomeEditing #Crispr #Biotechnology #Chemistry #ClinicalTrial #FDA #FastTrack #Licensing #University

J Davis 🫂🕊️
2 months ago

@arstechnica

#MugShots #GenesisII
#FDA #QuackHack

Dad, #MarkGrenon 65, son Jonathon 37, son Jordan 29, don Joseph 35

I thought they deserved to be seen like any criminal.

Four pics of dad, Mark Grenon 65, son Jonathon 37, son Jordan 29, son Joseph 35 

FL family formed fake church, Genesis Il, and sold toxic, industrial bleach as a miracle cure for HIV, cancer, COVID-19, etc. since 2014. Allegedly.
Laffy
2 months ago

#FDA approves antibody to protect infants from #RSV

“Nirsevimab, which will be sold under the brand name Beyfortus, is not a vaccine. Vaccines prompt the body to make antibodies to defend against pathogens. Instead, nirsevimab is a form of passive immunity. It’s a ready-made antibody that can bind to the virus and block it from infecting healthy cells. The immune system doesn’t have to make anything.” #health

https://www.cnn.com/2023/07/17/health/rsv-antibody-nirsevimab

Steve Herman
2 months ago

#FDA approves a birth control pill to be sold without a prescription for the first time in the US. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

Omar Moore
2 months ago

BREAKING: FDA approves the first over-the-counter birth control pill in the US. https://bit.ly/43qiWMb #FDA #Mastodon #BlackMastodon

Laffy
2 months ago

Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States. #FDA #WomensHealthcare

https://www.cnn.com/2023/07/13/health/fda-otc-birth-control-opill

Flipboard News Desk
2 months ago

U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.

The AP reports the "FDA’s decision has no relation to the ongoing court battles over the abortion pill mifepristone."

https://flip.it/OfMIkS

#BirthControl #FDA #Medicine #Health #Women #WomensHealth

Jeff Gilchrist
2 months ago

Novavax Fall 2023 Vaccine Booster Update

#Novavax presented at the June 15th #FDA #VRBPAC meeting to provide neutralization results from testing with various combinations of the original #vaccine, #BA.5, #XBB.1.5 and #XBB.1.16 #boosters. This thread will highlight the presentation. 🧵 1/

An unrolled one-page web view for this long thread that may be easier to read or share can be found here ( https://twitter.com/jeffgilchrist/status/1678356489449140226 )

Photo of Novavax initial slide at FDA VRBPAC meeting on June 15, 2023
Laffy
3 months ago

The #FDA gave full approval to the #Alzheimer’s drug Leqembi, and #Medicare said it would cover much of its high cost, laying the foundation for widespread use of the medication

https://breaking.iavian.net/article/340110

#FDA grants full approval to new #Alzheimer's drug meant to slow disease

https://flip.it/XztCTU

Laffy
3 months ago

#FDA has approved blood test that can identify pregnant women who are at imminent risk of developing a severe form of high blood pressure called pre-eclampsia, a leading cause of disability and death among childbearing women.

The condition disproportionately affects Black women in the United States…”
#health #WomensHealth

https://www.nytimes.com/2023/07/03/health/pregnancy-preeclampsia-test.html?smid=nytcore-ios-share&referringSource=articleShare

Steve Herman
3 months ago

AP: Thousands of unauthorized #vapes are pouring into the US despite the #FDA crackdown on fruity flavors. https://apnews.com/article/80b2680a874d89b8d651c5e909e39e8f

christy
3 months ago

Oh good, FDA is banning ElfBar disposable vapes. Children poisoned.

Since gun accidents are the leading cause of death of children in the US, and opioids are the leading cause of poison fatalities in children, surely these are also getting banned? Regulated? A little? No?

I hate everything at the moment.

#vaping #fda #GunSafety

Laffy
3 months ago

💉A panel of #FDA advisers votes in favor of updating #Covid-19 #vaccines this fall to include just one circulating strain of the coronavirus

https://www.cnn.com/2023/06/15/health/fda-advisers-covid-19-boosters/index.html

ProPublica
3 months ago

Scores of Critical Lab Tests Fall Into a Regulatory Void. The #FDA Is Trying to Close It.
==

Lab-developed tests like #prenatal screenings have become increasingly popular, all while escaping the bulk of federal scrutiny over #marketing and accuracy. Now, the FDA is beginning the process of imposing regulations on these kinds of tests.

#Health #HealthCare #Pregnancy #Regulation

https://www.propublica.org/article/fda-moves-to-regulate-lab-developed-tests?utm_medium=social&utm_source=mastodon&utm_campaign=mastodon-post

Laffy
4 months ago

#FDA approves Pfizer #RSV vaccine for older adults

https://breaking.iavian.net/article/337792

Cory Doctorow
4 months ago

Skolnick is a physicist by training, but has a long history of collaboration with #OpenBiome, a nonprofit that coordinates between doctors, patients and donors to provide safe FMTs:

https://stephenskolnick.substack.com/

In a Dec '22 Eat Shit post, Skolnick recounts the amazing history and dismaying future of FMTs. In 2013, the #FDA announced it would regulate FMTs as "Investigational New Drugs," which could only be administered through a registered clinical trial:

https://stephenskolnick.substack.com/p/a-monopoly-on-poop

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