FDA

Amgen's request for full approval of Lumakras in lung cancer denied by FDA
Fierce Pharma
Wed, 12/27/23 - 11:02 pm
Amgen
Lumakras
FDA
non-small cell lung cancer
FDA grants priority review for Daiichi Sankyo-Merck’s lung cancer therapy
Pharmaceutical Business Review
Wed, 12/27/23 - 11:00 pm
Daiichi Sankyo
Merkc
patritumab deruxtecan
FDA
non-small cell lung cancer
FDA approves Ionis-AstraZeneca's nerve disease drug
Reuters
Fri, 12/22/23 - 09:42 am
Ionis Pharmaceuticals
AstraZeneca
FDA
Wainua
ATTR-PN
FDA warns about counterfeit versions of Novo's diabetes drug Ozempic
Reuters
Fri, 12/22/23 - 09:40 am
Novo Nordisk
FDA
Ozempic
diabetes
drug counterfeiting
Merck’s Chronic Cough Drug Fails to Secure FDA Approval for Second Time
BioSpace
Thu, 12/21/23 - 11:36 am
Merck
gefapixant
chronic cough
FDA
FDA Denies Accelerated Approval for Clene’s ALS Candidate
BioSpace
Thu, 12/21/23 - 11:31 am
Clene
ALS
FDA
CNM-Au8
Takeda’s Fruzaqla (Fruquintinib) Gets FDA Nod for Metastatic Colorectal Cancer
Xtalks
Thu, 12/21/23 - 09:42 am
Takeda
FDA
colorectal cancer
fruquintinib
Fruzaqla
FDA identifies recall of Philips medical imaging devices as most serious
Reuters
Wed, 12/20/23 - 06:37 pm
FDA
Medtech
Philips
Medical Imaging
product recalls
Market for CAR-Ts Still Bright Despite FDA Cancer Safety Review
BioSpace
Wed, 12/20/23 - 09:36 am
CAR-T
FDA
cancer
FDA accepts Merck’s pneumococcal vaccine BLA for priority review
Pharmaceutical Technology
Wed, 12/20/23 - 09:34 am
Merck
vaccines
FDA
pneumococcal disease
V116
FDA approves first test to identify opioid use addiction risk
Reuters
Wed, 12/20/23 - 09:26 am
AvertD
Medtech
diagnostics
SOLVD Health
FDA
opioid addiction
opioids
FDA Facing Increased Scrutiny Over Medical Device Recalls
Medical Devices and Diagnostics Industry
Tue, 12/19/23 - 11:17 pm
FDA
Medtech
device recalls
Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval
MedCity News
Tue, 12/19/23 - 11:13 pm
Chiesi
Filsuvez
FDA
epidermolysis bullosa
Roche, Novartis move Xolair closer to FDA finish line for food allergies
Fierce Pharma
Tue, 12/19/23 - 11:10 pm
Roche
FDA
Xolair
food allergies
Novartis
FDA approves safety labeling changes for opioids
Pharmacist.com
Mon, 12/18/23 - 10:07 pm
FDA
labeling
opioids
FDA Finds Quality Control Problems at Moderna’s Vaccine Facility: Reuters
BioSpace
Mon, 12/18/23 - 10:18 am
Moderna Therapeutics
vaccines
drug manufacturing
FDA
Oncologists Defend CAR-T After FDA Advisory
BioSpace
Mon, 12/18/23 - 10:11 am
oncologists
CAR-T
cancer
FDA
House lawmakers threaten FDA with subpoena amid probe into overseas inspections
Fierce Pharma
Sun, 12/17/23 - 09:55 pm
FDA
regulatory
foreign inspections
Glaukos eye implant swings FDA approval
Clinical Trials Arena
Sun, 12/17/23 - 09:51 pm
Glaukos
FDA
ocular hypertension
iDose
FDA Puts Clinical Hold on Three CARsgen Therapeutics CAR-T Candidates
BioSpace
Fri, 12/15/23 - 11:14 am
CARsgen
FDA
cell therapy
CAR-T

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