FDA

Moderna's flu/COVID combination vaccine hit by deprioritization, FDA delay
Fierce Biotech
Thu, 05/1/25 - 10:57 am
Moderna Therapeutics
vaccines
earnings
FDA
mRNA-1083
Imfinzi approval positions AstraZeneca at forefront of perioperative MIBC
Clinical Trials Arena
Wed, 04/30/25 - 11:45 pm
AstraZeneca
Imfinzi
muscle-invasive bladder cancer
FDA
J&J secures FDA OK for immune drug touted as future blockbuster
BioPharma Dive
Wed, 04/30/25 - 11:39 pm
JNJ
FDA
Imaavy
nipocalimab
myasthenia gravis
Entrada lays off 20% of staff weeks after having FDA hold lifted
Fierce Biotech
Wed, 04/30/25 - 11:05 am
Entrada
DMD
FDA
layoffs
FDA misses approval deadline for biotech’s rare disease drug
BioPharma Dive
Wed, 04/30/25 - 10:55 am
FDA
Stealth BioTherapeutics
drug approvals
Rare Diseases
elamipretide
Barth Syndrome
Medtronic Files for FDA Submission for the Hugo Robotic System
Medical Devices and Diagnostics Industry
Mon, 04/28/25 - 09:40 am
Medtech
Medtronic
Hugo
robotic surgery
FDA
FDA’s job cuts paint mixed picture for drugmakers’ R&D plans
Pharma Voice
Mon, 04/28/25 - 09:32 am
FDA
layoffs
R&D
FDA puts Vyne in a twist, slapping hold on psoriasis trial over testicular toxicity concerns
Fierce Biotech
Fri, 04/25/25 - 11:17 am
Vyne Therapeutics
FDA
psoriasis
clinical trials
Medtronic seeks FDA nod for insulin pump, furthering Abbott collab
Medtech Dive
Fri, 04/25/25 - 10:47 am
Medtech
Medtronic
FDA
insulin pump
Abbott Labs
CGMs
diabetes
Ex-FDA leader joins new initiative designed to fight 'unfortunate reality' of vaccine landscape
Fierce Biotech
Thu, 04/24/25 - 09:14 pm
vaccines
FDA
Margaret Hamburg
HHS
misinformation
Key FDA drug data goes missing amid DOGE cuts
Axios
Thu, 04/24/25 - 10:41 am
FDA
regulatory
drug safety
DOGE
layoffs
Vanda sues FDA over hearing delay as agency points to mass layoffs, other litigation with the biopharma
Fierce Biotech
Wed, 04/23/25 - 10:23 pm
Vanda Pharmaceuticals
FDA
legal
tradipitant
Novavax reveals FDA request for additional data
Investing.com
Wed, 04/23/25 - 09:54 am
Novavax
vaccines
COVID-19
FDA
Precision Neuroscience receives FDA clearance for brain implant
Medtech Dive
Tue, 04/22/25 - 07:39 pm
Medtech
Precision Neurosciences
brain implant
FDA
Medtronic Heats CGM Space Up with New FDA Nod
Medical Devices and Diagnostics Industry
Tue, 04/22/25 - 11:01 am
Medtech
Medtronic
CGMs
diabetes
Simplera Sync
FDA
Novo says it’s submitted obesity pill for FDA approval
BioPharma Dive
Mon, 04/21/25 - 06:13 pm
Novo Nordisk
Wegovy
obesity
oral Wegovy
FDA
FDA fires most negotiators for pharma user fee talks, sources say
Yahoo/Reuters
Mon, 04/21/25 - 06:10 pm
FDA
layoffs
drug reviews
user fees
U.S. District Court Grants Summary Judgment in Favor of FDA, Salix, and Teva, and Against Norwich
Stock Titan
Mon, 04/21/25 - 05:59 pm
legal
Bausch Health
Salix Pharmaceuticals
FDA
Norwich Pharmaceuticals
Xifaxin
Makary Discusses Expedited Rare Disease Approvals Pathway, ‘Public Distrust’ in New Interview
BioSpace
Mon, 04/21/25 - 05:56 pm
FDA
Marty Makary
Rare Diseases
drug approvals
regulatory
Sanofi, Regeneron win FDA nod for Dupixent in chronic hives
BioPharma Dive
Mon, 04/21/25 - 11:13 am
Sanofi
Regeneron
Dupixent
FDA
chronic hives

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