FDA

FDA approves first-of-its-kind RNA drug for hemophilia
BioPharma Dive
Sun, 03/30/25 - 10:26 pm
Sanofi
FDA
fitusiran
Qfitlia
hemophilia
FDA declines to approve Milestone's heart rhythm nasal spray
MSN/Reuters
Fri, 03/28/25 - 11:27 am
FDA
Milestone Pharmaceuticals
Cardamyst
Dexcom’s FDA warning letter reveals unauthorized changes to sensors
Medtech Dive
Thu, 03/27/25 - 11:18 am
Medtech
DexCom
continuous glucose monitoring
diabetes
CGMs
FDA
FDA staff struggle to meet product review deadlines after DOGE layoffs
MSN/Reuters
Thu, 03/27/25 - 11:09 am
FDA
regulatory
Medtech
devices
DOGE
FDA fast-tracks Sanofi's experimental chlamydia vaccine
Pharmaphorum
Thu, 03/27/25 - 11:05 am
Sanofi
vaccines
chlamydia
FDA
First Prader-Willi drug to reduce hunger approved by FDA
BioPharma Dive
Wed, 03/26/25 - 10:14 pm
Soleno Therapeutics
FDA
Prader-Willi Syndrome
Vykat XR
Makary confirmed by Senate as FDA commissioner
BioPharma Dive
Wed, 03/26/25 - 10:12 pm
Martin Makary
FDA
To approve Exelixis' Cabometyx in neuroendocrine tumors, FDA recognizes 'crossover impact' on survival
Fierce Pharma
Wed, 03/26/25 - 11:41 am
Exelixis
Cabometyx
neuroendocrine tumors
FDA
FDA commissioner's abortion pill minefield
Axios
Wed, 03/26/25 - 10:26 am
FDA
Marty Makary
abortion pill
mifepristone
Wave's DMD drug remains on track in 48-week data ahead of FDA push next year
Fierce Biotech
Wed, 03/26/25 - 10:17 am
Wave Life Sciences
DMD
Duchenne Muscular Dystrophy
FDA
GSK ushers in new UTI antibiotic with FDA nod for first-in-class Blujepa
Fierce Pharma
Tue, 03/25/25 - 09:56 pm
GSK
FDA
Blujepa
antibiotics
UTIs
FDA aligns with Imunon’s Phase III trial protocol for ovarian cancer treatment
Clinical Trials Arena
Tue, 03/25/25 - 11:21 am
Imunon
FDA
clinical trials
IMNN-001
ovarian cancer
FDA starts review of Sanofi's MS hope tolebrutinib
Pharmaphorum
Tue, 03/25/25 - 10:20 am
Sanofi
FDA
tolebrutinib
MS
multiple sclerosis
FDA rejects Hengrui, Elevar's PD-1 cancer drug combination—again
Fierce Pharma
Sun, 03/23/25 - 11:43 pm
Jiangsu Hengrui
Elevar Therapeutics
camrelizumab
FDA
cancer
Novartis' Fabhalta is first FDA-approved therapy for rare disease C3G
Pharmaphorum
Fri, 03/21/25 - 11:19 am
Novartis
FDA
Fabhalta
C3 glomerulopathy
Alnylam drug gets long-awaited FDA approval in deadly heart disease
BioPharma Dive
Thu, 03/20/25 - 10:05 pm
Alnylam
Amvuttra
Pfizer
Bridge Bio
FDA
ATTR-CM
J&J advances Stelara succession scheme with key FDA nod for Tremfya in Crohn's disease
Fierce Pharma
Thu, 03/20/25 - 10:03 pm
JNJ
Tremfya
FDA
Crohn's Disease
Some FDA staff considering quitting due to Trump’s RTO policy
RAPS.org
Wed, 03/19/25 - 11:15 pm
FDA
Donald Trump
remote work
J&J's nipocalimab fast-tracked for Sjogren's disease
Pharmaphorum
Wed, 03/19/25 - 11:13 am
JNJ
nipocalimab
FDA
fast track
Sjögren’s syndrome
FDA’s return-to-office chaos, probationary workers reinstated, and demotion fears
RAPS.org
Mon, 03/17/25 - 10:18 pm
FDA
White Oak

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