FDA

FDA's top inspector abruptly retires
CBS News
Tue, 05/6/25 - 09:41 pm
FDA
drug inspections
regulatory
FDA Commissioner Marty Makary taps Vinay Prasad to head up CBER
Fierce Pharma
Tue, 05/6/25 - 09:30 pm
FDA
Marty Makary
CBER
Vinay Prasad
Trump orders FDA to help speed building of new drug factories
BioPharma Dive
Tue, 05/6/25 - 09:27 pm
Donald Trump
FDA
drug manufacturing
US cancels FDA bargaining session over layoffs, union says
MSN/Reuters
Tue, 05/6/25 - 10:29 am
Donald Trump
FDA
layoffs
unions
Trump administration will defend FDA against abortion pill lawsuit, asks for dismissal
The Hill
Mon, 05/5/25 - 10:54 pm
DOJ
Donald Trump
FDA
abortion pill
mifepristone
Novo’s Wegovy inches closer to becoming first FDA-approved GLP-1 weight-loss pill
BioSpace
Mon, 05/5/25 - 11:29 am
Novo Nordisk
Wegovy
FDA
obesity
weight loss
Capricor Therapeutics announces completion of mid-cycle review meeting with FDA on deramiocel for the treatment of Duchenne Muscular Dystrophy cardiomyopathy
Stock Titan
Mon, 05/5/25 - 11:20 am
Capricor
DMD
DMD cardiomyopathy
FDA
deramiocel
US FDA asks some fired pharma user fee negotiation staff to return
MSN/Reuters
Sun, 05/4/25 - 12:02 pm
FDA
layoffs
user fees
FDA frees Amgen's phase 1 obesity asset from clinical trial hold
Fierce Biotech
Fri, 05/2/25 - 11:18 am
FDA
Amgen
obesity
clinical trials
AMG 513
Intuitive earns expanded FDA nod for da Vinci single port system
Mass Device
Fri, 05/2/25 - 10:53 am
Medtech
Intuitive Surgical
FDA
da Vinci single port
robotic surgery
FDA delays decision date on Cytokinetics' heart drug to year-end in unusual safety program back-and-forth
Fierce Biotech
Fri, 05/2/25 - 10:47 am
Cytokinetics
aficamten
FDA
obstructive hypertrophic cardiomyopathy
FDA resurrects Satsuma's nasal migraine treatment
Pharmaphorum
Fri, 05/2/25 - 10:44 am
Satsuma Pharmaceuticals
FDA
Atzumi
migraines
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

Pages