FDA

mRNA Skepticism Threatens a Promising Technology Undark07:15Moderna Vaccine Moderna mRNA

FDA vaccines chief Vinay Prasad to step down in April NewsMax23:03Moderna Vaccine Moderna mRNA

Manila clams shipped to Florida, 8 other states recalled over norovirus concerns, FDA says WFLX16:42Norovirus Manila Health

Clams, raw oysters recalled over possible norovirus contamination across 9 states: FDA Fox News01:46Norovirus Manila Health

FDA warns Novo Nordisk over unreported potential Ozempic side effects CBS News17:55Novo Nordisk Ozempic Pharma

Ozempic's drug maker, Novo Nordisk, receives FDA warning letter over unreported side effects:… Mint18:47Novo Nordisk Ozempic Pharma

FDA rejects uniQure Huntington's gene therapy AMT-130, demands randomised trial Manufacturing Chemist12:21uniQure Biology Pharma

FDA Defends Call For Placebo Study In uniQure Huntington's Gene Therapy Trial Benzinga17:19uniQure Biology Pharma

FDA finds little evidence that Drug touted by Trump can help people with autism WTTW17:42Autism The Lancet Pharma

FDA finds little evidence that a drug touted by Trump can help people with autism Boulder Daily Camera, Colorado16:35Autism The Lancet Pharma

Johnson & Johnson’s multiple myeloma treatment approved by US FDA PMLiVE12:51Johnson and Johnson Cancer Treatment Pharma

J&J announces Tecvayli-Darzalex combo approval from FDA for multiple myeloma Pharmaceutical Technology11:56Johnson and Johnson Cancer Treatment Pharma

Are you being misled by GLP-1 ads? FDA issues 30 telehealth companies warning letters The Dallas Express13:01Pharma

A “New era” of consumer medicine? FDA takes another swipe at “Unapproved” compounded drugs National Law Review19:21Pharma

650,000 Gallons of bottled water recalled, per FDA Prevention.com13:41

Over 651,000 bottled water units recalled due to 'Insanitary conditions' in production, FDA says International Business Times - AU Edition12:06

STAT Plus: Pharmalittle: We’re reading about Moderna’s $2.25 billion settlement, FDA warning… STAT14:20Moderna Pharma

Novavax outlines path after FDA delay DevX.com19:16Moderna Pharma

Power-hungry FDA is hazardous to our health The Independent Institute (Weblog)14:08Pharma

Seastar medical completes FDA enrollment requirement for save registry in pediatric aki RTT News15:09Pharma

Latest News

In the last 5 minutes

STAT Plus: GOP senator is investigating the FDA over rejections of rare disease drugs STAT21:38

In the last half-hour

Qiagen Receives U.S. Clearance for Gastrointestinal Panels on Fully Automated QIAstat-Dx Rise… Business Wire (Press Release)21:13

In the last hour

FDA Reverses Stance on Leucovorin for Autism Medpage Today21:07

US FDA draft guidance eases another biosimilar requirement BioWorld21:05

Denali ‘Moving In A Positive Direction’ With FDA Toward Hunter Drug Action Date Scrip Pharma Intelligence21:01

In the last 2 hours

Anti-Choking Device LifeVac Gets FDA Clearance NewsMax20:38

Biologics and Biosimilars Landscape 2025: IP, Policy, and Market Developments JD Supra20:36

Shellfish recalled in Washington, Oregon over possible norovirus contamination KUOW Public Radio20:35

Karl Storz Receives FDA Clearance for five S 6.5 Bronchoscope Business Wire (Press Release)20:02

In the last 4 hours

A “New Era” of Consumer Medicine? FDA Takes Another Swipe at “Unapproved” Compounded Drugs National Law Review19:21

FDA Announces Bottled Water Recall: More Than Half a Million Gallons Packaged Under 'Insanitary Conditions' Health Magazine19:17

Novavax Outlines Path After FDA Delay DevX.com19:16

Back to the Well: FDA’s Draft Guidance on New Clinical Investigation Exclusivity JD Supra19:04

Ozempic's drug maker, Novo Nordisk, receives FDA warning letter over unreported side effects:… Mint18:47

Why the controversial head of FDA's vaccine unit is stepping down WUWM18:42

GEHC Wins FDA 510(k) Approval for View, Enhances Radiology Workflows Zacks18:18

FDA Outlines Risk-Based Approach to ENDS Flavors Tobacco Reporter Magazine18:09

Trump’s divisive FDA vaccine regulator self-destructs, will exit agency (again) Ars Technica18:04

FDA warns Novo Nordisk over unreported potential Ozempic side effects CBS News17:55

FDA Finds Little Evidence That Drug Touted by Trump Can Help People With Autism WTTW17:42

In the last 6 hours

FDA Recalls Seafood In Nine States Rock Hill Herald16:54

Raw Oysters, Clams Recalled Across 9 States for Potential Norovirus Contamination People16:49

Manila clams shipped to Florida, 8 other states recalled over norovirus concerns, FDA says WFLX16:42

Novo Warned on Lax Reporting of Ozempic Side Effects, Deaths (1) Bloomberg Law16:36

FDA finds little evidence that a drug touted by Trump can help people with autism Boulder Daily Camera, Colorado16:35

FDA homes in on biosimilar accessibility in new draft guidance Pharmaceutical Technology16:34

FDA approves leucovorin to treat rare cerebral folate deficiency UPI16:32

Leucovorin lacks evidence to use as autism treatment, FDA says STAT16:32

NeuroPace's Seizure ID and New Indication Could Expand RNS Demand Zacks16:26

Clams shipped to Fla., other states recalled over norovirus concerns WPTV, Florida16:25

Vinay Prasad to exit Cber as FDA group director European Pharmaceutical Review16:22

FDA finds little evidence that the generic drug leucovorin can help people with autism PBS Online16:14

Clarapath Launches Its Latest SectionStar™ Platform for Clinical Histology Workflows PR Newswire (Press Release)16:05

FDA removes black box warning from hormone therapy ABC News16:00

Novo Nordisk's US headquarters under fire in latest FDA warning letter FiercePharma15:43

In the last 8 hours

FDA approves leucovorin – but not for autism pharmaphorum15:36

Seafood Recalled Nationwide Over Possible Norovirus Contamination—What to Know Martha Stewart15:36

FDA declines to approve $2.50 'autism pill' that families claim reversed their children's… MailOnline15:33

FDA Approves Drug for Rare Autism-Linked Disorder NewsMax15:20

FDA finds little evidence that a generic drug can help people with autism ABC News15:17

Orbia Fluor & Energy Materials registers US DMF file for low-GWP propellant Manufacturing Chemist15:09

Louisiana’s Legal Fight Against Mailed Abortion Pills: A Timeline Rewire News14:56

STAT Plus: Novo Nordisk is warned by the FDA for failing to report side effects STAT14:54

Seafood distributed in Florida recalled, possible norovirus contamination: FDA Tampa Bay 2814:38

Capricor Therapeutics Stock Gains Over New Pdufa Date For Deramiocel Bla RTT News14:05

Oral Contraceptive Pills: Access and Availability The Henry J. Kaiser Family Foundation14:02

FDA finds little evidence that generic drug leucovorin could help many people with autism The Washington Times14:00

Sen. Ron Johnson Launches Probe Into FDA Denials of Rare Disease Treatments NewsMax13:42

FDA approves generic drug for rare brain disorder but not autism CBS Austin13:40

Earlier today

STAT Plus: Pharmalittle: We’re reading about a U.S. senator probing FDA, BioNTech founders… STAT13:28

FDA finds little evidence that a generic drug could help many people with autism MailOnline13:16

FDA approves leucovorin for ultrarare cerebral folate deficiency subset without clinical trial FiercePharma13:01

QT Imaging Receives FDA Clearance for Its Breast Acoustic CT Scanner Enhanced Configuration to… Business Wire (Press Release)12:31

Eledon Pharma: FDA Grants Orphan Drug Designation To Tegoprubart RTT News12:23

ReVision Implant eyes FIH trial for BCI after FDA breakthrough designation Verdict Medical Devices12:19

Novo and Hims & Hers become partners to end legal feud Pharmaceutical Technology11:18

Else Nutrition Expected to Benefit from FDA Regulatory Progress on Infant Formula Protein… PR Newswire (Press Release)11:05

GE HealthCare secures FDA 510(k) clearance for diagnostic viewer Verdict Medical Devices10:57

Innoviva Specialty Therapeutics Earns Strong Performance Rating in Access to Medicine… Business Wire (Press Release)10:32

Centauri Therapeutics Granted FDA Qidp Status for Ctx-187 Treatment of Gram-Negative Bacterial… Business Wire (Press Release)10:32

The perpetual grain-free debate | Casey’s Corner Chico Enterprise-Record, California10:31

Children's Hospital Los Angeles Expands to 12 FDA-Approved Cell and Gene Therapies Newswise (Press Release)10:05

Republican Launches Investigation Into Trump Admin FDA Denials Macon.com09:44

Nuformix shares jump 12.5% as FDA grants orphan drug status for rare lung disease programme Proactive Investors (UK)08:47

Why did Cipla USA recall over 400 cartons of cancer drugs? The Financial Express08:22

Why the FDA Is Embracing Old Math for New Drugs Undark08:10

FDA Issues Landmark Biosimilar Guidance Incorporating Regulatory Reforms Advised by Professor… PR Newswire (Press Release)05:32

Justice Jackson Was Partly Mistaken About Mifepristone Reason04:04

Cardinal Health Biosimilar Report: $56 Billion in Savings and the Road to Market Sustainability Center for Biosimilars02:44

FDA Approves Filkri, Accord BioPharma’s Short-Acting Filgrastim Biosimilar for Neutropenia Center for Biosimilars02:44

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job Center for Biosimilars02:44

Health Care Week in Review | HHS and ED Announce Medical School Commitments to Increase Nutrition Education; Energy &… JD Supra02:19

Clams, raw oysters recalled over possible norovirus contamination across 9 states: FDA Fox News01:46

Vertex rises after kidney drug meets goal in late-stage trial Boston Globe00:31

Key US Senator Investigates FDA Over Rare-Disease Drug Denials Bloomberg Law00:16

Yesterday

FDA opens door to more flavored e-cigarettes Pittsburgh Tribune-Review23:33 9-Mar-26

FDA unveils 4th revision of draft guidance for looser biosimilar testing requirements FiercePharma21:36 9-Mar-26

Hims & Hers: Repartnering With Novo Removes Legal Overhang and Reshapes Weight Loss Segment MorningStar.com21:33 9-Mar-26

Cancer Drug Pulled From Market Over Safety Concerns Medpage Today21:32 9-Mar-26

Food Advisory Issued For Oysters & Manila Clams Delish21:12 9-Mar-26

FDA issues urgent warning over clams and oysters The Independent20:46 9-Mar-26

NDSee You in 2033: FDA’s 12‑Digit NDC Is Coming JD Supra20:32 9-Mar-26

GRAS update proposal coming this spring, says FDA food chemical safety chief Chemical & Engineering News20:06 9-Mar-26

Axsome Therapeutics CEO Completes Planned $6 Million Options Sale Ahead of Pivotal FDA Decision The Motley Fool20:04 9-Mar-26

UniQure Leads Biotechs Heartened By Prasad’s Second FDA Exit Scrip Pharma Intelligence17:23 9-Mar-26

Hims & Hers abandons plan for cheaper Wegovy knockoff after FDA warning Los Angeles Times17:16 9-Mar-26

BMY Wins FDA Nod to Expand Sotyktu Label for Psoriatic Arthritis Zacks17:10 9-Mar-26

Hims & Hers Shares Surge 42% On Novo Nordisk Collaboration RTT News17:02 9-Mar-26

FDA Announces Coconut Water Recall—180,000 Cans Pulled From Shelves in 11 States Health Magazine16:41 9-Mar-26

Snakebite pill backed by Talking Heads rocker nears FDA approval Silicon Valley/San Jose Business Journal16:25 9-Mar-26

Sotyktu take 2: BMS' first-in-class pill gains FDA nod to treat psoriatic arthritis FiercePharma15:30 9-Mar-26

ImmunityBio Announces FDA Resubmission For Expanded Use Of Lead Drug Benzinga15:10 9-Mar-26

First Patient Dosed in Emalex Biosciences’ Expanded Access Program for Investigational Tourette … Business Wire (Press Release)15:09 9-Mar-26

Drug Compounder Loses Challenge to FDA Bulk Substance Decision Bloomberg Law14:56 9-Mar-26

CNS Drug Developers Add Pharma Veterans as Sector Nears First FDA Decisions PR Newswire (Press Release)14:55 9-Mar-26

Novo's troubled Indiana plant claims another victim as FDA rejects Incyte's lung cancer… FiercePharma14:50 9-Mar-26

FDA issues 3-year exclusivity draft guidance clarifying requirements to obtain exclusivity and providing model language … JD Supra14:25 9-Mar-26

FDA Vaccine Chief Dr. Vinay Prasad Exiting Role HealthDay13:51 9-Mar-26

Fresh turmoil at the FDA with Prasad’s exit STAT13:26 9-Mar-26

STAT Plus: Pharmalot: We’re reading about a lack of FDA adcomms, FDA loosening biosimilar… STAT13:14 9-Mar-26

Vinay Prasad leaves FDA again amid dispute over Huntington’s disease treatment British Medical Journal13:11 9-Mar-26

GE HealthCare announces U.S. FDA 510(k) clearance for View, a next‑generation diagnostic viewer … Business Wire (Press Release)13:01 9-Mar-26

Johnson & Johnson’s multiple myeloma treatment approved by US FDA PMLiVE12:51 9-Mar-26

Novo Nordisk expands US patient access to FDA-approved semaglutide medicines through Hims & Hers in response to a shift … Novo Nordisk12:50 9-Mar-26

Hims & Hers Announces Strategic Shift for US Weight Loss Business Business Wire (Press Release)12:34 9-Mar-26

American Society of Breast Surgeons (ASBrS) Resource Guide Update Recommends Cryoablation for… PR Newswire (Press Release)12:33 9-Mar-26

FDA rejects uniQure Huntington's gene therapy AMT-130, demands randomised trial Manufacturing Chemist12:21 9-Mar-26

Over 100 unreviewed chemicals found in everyday US foods, study reveals New Food11:51 9-Mar-26

Vinay Prasad to leave the FDA again Pharmaceutical Technology11:36 9-Mar-26

Philips advances cardiac MR with FDA clearance for SmartHeart AI Verdict Medical Devices11:34 9-Mar-26

ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA® Plus BCG in… PR Newswire (Press Release)11:31 9-Mar-26

Spruce Biosciences Reports Full Year 2025 Financial Results and Provides Corporate Updates Business Wire (Press Release)11:06 9-Mar-26

Enhertu® (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US as… Business Wire (Press Release)11:06 9-Mar-26

enGene Reports First Quarter 2026 Financial Results and Provides Business Update Business Wire (Press Release)11:06 9-Mar-26

Precision BioSciences Receives FDA Fast Track Designation for Pbgene-Dmd and Announces Duchenne … Business Wire (Press Release)11:05 9-Mar-26

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10 Mar 21:38

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