FDA

Veru needs additional cash for fresh trial of respiratory distress drug
Fierce Biotech
Thu, 02/8/24 - 11:09 am
Veru
respiratory distress
RSV
COVID-19
FDA
Drug Shortages Aren’t Over. And There’s Little Progress Toward Ending Them
BioSpace
Wed, 02/7/24 - 09:24 pm
FDA
GAO
drug shortages
FDA puts hold on Gilead's blood cancer therapy trials
Reuters
Wed, 02/7/24 - 09:20 pm
Gilead Sciences
FDA
clinical trials
magrolimab
blood cancer
Eisai, Biogen likely to miss early launch goal for Alzheimer's drug Leqembi
Fierce Pharma
Wed, 02/7/24 - 11:33 am
Eisai
Biogen
FDA
Medicare
Leqembi
Alzheimer's disease
FDA finds control lapses at Catalent plant being sold to Novo
Reuters
Tue, 02/6/24 - 11:36 pm
FDA
drug manufacturing
regulatory
Novo Nordisk
Catalent
FDA Clears First Non-drug Prescription Device for Women with Osteopenia
Medical Devices and Diagnostics Industry
Tue, 02/6/24 - 11:25 pm
Medtech
FDA
osteopenia
OsteoBoost
Bone Health Technologies
FDA awarded record number of review designations to CRISPR drugs in 2023
Biopharma Reporter
Tue, 02/6/24 - 09:16 am
CRISPR
FDA
gene editing
CRISPR Therapeutics
Vertex Pharmaceuticals
Valneva sells regulatory ‘fast pass’ for $103M
BioPharma Dive
Tue, 02/6/24 - 09:14 am
Valneva
FDA
fast pass
Ixchiq
FDA officials say different communication methods needed to ensure AI/ML transparency
RAPS.org
Mon, 02/5/24 - 10:52 pm
FDA
artificial intelligence
machine learning
transparency
FDA website shows limited availability of some doses of Lilly's Mounjaro
Reuters
Mon, 02/5/24 - 10:12 am
FDA
drug shortages
Eli Lilly
Mounjaro
FDA approves NeuroBo’s DA-1726 application to begin Phase I trial
Clinical Trials Arena
Fri, 02/2/24 - 11:55 am
NeuroBo Pharmaceuticals
DA-1726
FDA
clinical trials
obesity
Edwards receives FDA approval for first transcatheter tricuspid valve replacement treatment
Medtech Dive
Fri, 02/2/24 - 11:51 am
Medtech
Edwards Lifesciences
FDA
tricuspid trascatheter valve
Evoque
FDA commissioner Robert Califf: Adcomm reforms coming, praises AI potential
Medical Marketing and Media
Thu, 02/1/24 - 11:23 am
FDA
Robert Califf
artificial intelligence
drug shortages
Gilead’s Kite Gets FDA Approval for Faster CAR T Therapy Manufacturing
BioSpace
Wed, 01/31/24 - 11:58 am
Gilead Sciences
Kite Pharma
FDA
drug manufacturing
Yescarta
CAR-T
FDA approval numbers soar after COVID troubles
Pharmaphorum
Wed, 01/31/24 - 11:51 am
FDA
drug approvals
pandemic
COVID-19
FDA approves Farapulse pulsed field ablation tech from Boston Scientific
Mass Device
Wed, 01/31/24 - 11:48 am
Medtech
Boston Scientific
FDA
Farapulse
pulsed field ablation
FDA Clears Ascidian for First-Ever RNA Editing Trial in US
BioSpace
Tue, 01/30/24 - 09:22 pm
Ascidian Therapeutics
FDA
clinical trials
Stargardt disease
RNA editing
FDA lifts clinical hold on INmune Bio’s Phase II Alzheimer’s trial
Clinical Trials Arena
Tue, 01/30/24 - 09:19 pm
INmune Bio
clinical trials
Alzheimer's disease
Xpro
FDA
CellVax receives FDA clearance for prostate cancer drug trial
Clinical Trials Arena
Tue, 01/30/24 - 10:47 am
CellVax Therapeutics
FDA
FK-PC101
prostate cancer
clinical trials
FDA Revises Letter of Authorization for the Emergency Use Authorization for Paxlovid
Drugs.com
Mon, 01/29/24 - 10:21 pm
Paxlovid
COVID-19
Pfizer
FDA
Emergency Use Authorization

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