FDA

FDA cuts outlined in draft HHS budget
BioPharma Dive
Mon, 04/21/25 - 10:02 am
FDA
layoffs
HHS
How a scrapped Pfizer drug became a winner for SpringWorks
Pharma Voice
Mon, 04/21/25 - 10:00 am
SpringWorks Therapeutics
Pfizer
neurofibromatosis
mirdametinib
FDA
Allogene Granted Three U.S. FDA Fast Track Designations (FTD) for ALLO-329, a Next-Generation Dual-Targeted CD19/CD70 Allogeneic CAR T, for the Treatment of Lupus, Myositis and Scleroderma
Drugs.com
Wed, 04/16/25 - 10:55 pm
Allogene
FDA
CAR-T
fast track
ALLO-329
systemic lupus erythematosus
idiopathic inflammatory myopathy
diffuse systemic sclerosis
A judge blocked the FDA’s plan to regulate LDTs. What now?
Medtech Dive
Wed, 04/16/25 - 11:16 am
Medtech
LDTs
FDA
legal
diagnostics
FDA clears first migraine DTx from Click Therapeutics
Pharmaphorum
Wed, 04/16/25 - 11:11 am
Click Therapeutics
Medtech
digital therapeutics
DTx
CT-132
migraines
episodic migraines
FDA
Spruce smartens up pipeline with deal for BioMarin asset, plans 2026 approval filing
Fierce Biotech
Tue, 04/15/25 - 11:20 am
Spruce Biosciences
Biomarin
FDA
tralesinidase alfa
Sanfillipo Syndrome
Artificial Heart Takes Major Step Towards US Market
Medical Devices and Diagnostics Industry
Mon, 04/14/25 - 07:15 pm
Medtech
Carmat
Artificial Heart
Aeson
FDA
RFK Jr. blasts FDA as industry's 'sock puppet,' warns about 'deep state' influence at agency
Fierce Pharma
Mon, 04/14/25 - 07:13 pm
Robert F Kennedy Jr.
HHS
FDA
FDA after the storm: drug review delays and increased executive oversight expected
BioSpace
Mon, 04/14/25 - 11:02 am
FDA
regulatory
HHS
drug approvals
Intuitive wins FDA clearance for single-port robotic surgery stapler
Medtech Dive
Mon, 04/14/25 - 09:40 am
medtehc
Intuitive Surgical
FDA
robotic surgery
surgical stapler
Bristol Myers combo follows Roche, AstraZeneca immunotherapy rivals into first-line liver cancer
Fierce Pharma
Sun, 04/13/25 - 11:19 pm
Bristol Myers Squibb
Opdivo
Yervoy
hepatocellular carcinoma
FDA
Jobevne (Bevacizumab) Gains FDA Nod, Biocon Expands US Oncology Biosimilars Portfolio
Xtalks
Sun, 04/13/25 - 11:15 pm
Jobevne
bevacizumab-nwgd
Biocon Biologics
biosimilars
Avastin
cancer
FDA
After Hetlioz’s rejection in jet lag disorder, Vanda sues FDA for right to promote off-label use
Fierce Pharma
Sun, 04/13/25 - 11:11 pm
Hetlioz
Vanda Pharmaceuticals
jet lag disorder
FDA
Argenx stays on a roll with Vyvgart, gaining FDA nod for at-home prefilled syringe
Fierce Pharma
Fri, 04/11/25 - 11:27 am
Argenx
Vyvgart
Vyvgart Hytrulo
FDA
myasthenia gravis
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
Drugs.com
Thu, 04/10/25 - 09:51 pm
FDA
animal testing
monoclonal antibodies
Threat to FDA user fees program could set US back 35 years
BioSpace
Thu, 04/10/25 - 11:53 am
FDA
user fees
layoffs
DOGE
Donald Trump
Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts
BioPharma Dive
Thu, 04/10/25 - 11:48 am
biotech
venture capital
FDA
layoffs
FDA reverses course on telework after layoffs and resignations threaten basic operations
AP News
Thu, 04/10/25 - 11:26 am
FDA
DOGE
remote work
regulatory
layoffs
Regulating the invisible hand: Inside the FDA's AI playbook
Pharmaphorum
Thu, 04/10/25 - 11:19 am
FDA
regulatory
artificial intelligence
Tariffs are just part of pharma's Wall Street tumble
Axios
Wed, 04/9/25 - 11:16 am
pharma stocks
tariffs
FDA
regulatory
DOGE

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