FDA

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
FDA rejection of extended dosing interval is another piece of bad news for Regeneron’s Eylea HD
Fierce Pharma
Mon, 04/21/25 - 10:22 am
FDA
Regeneron
Eylea
CRL
FDA moves to block biopharma employees from serving on advisory committees
Fierce Pharma
Mon, 04/21/25 - 10:11 am
FDA
advisory committees
Marty Makary
regulatory
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

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