FDA

FDA's drug center to consolidate AI efforts under single council
Fierce Biotech
Thu, 08/29/24 - 06:10 pm
FDA
CDER
regulatory
artificial intelligence
J&J submits touted autoimmune disease drug for FDA approval
BioPharma Dive
Thu, 08/29/24 - 11:24 am
JNJ
myasthenia gravis
FDA
nipocalimab
FDA grants IND clearance for Find’s Phase I chronic optic neuropathy trial
Clinical Trials Arena
Wed, 08/28/24 - 09:12 pm
FDA
Find Therapeutics
IND
FTX-101
chronic optic neuropathy
clinical trials
EyePoint dinged with FDA warning letter over manufacturing shortfalls tied to eye implant
Fierce Pharma
Wed, 08/28/24 - 11:47 am
Eyepoint
FDA
eye implants
Medtech
After an FDA rejection, here’s what’s next in the psychedelics pipeline
BioPharma Dive
Wed, 08/28/24 - 11:41 am
psychedelics
FDA
Lykos Therapeutics
COMPASS Pathways
Incannex Healthcare
MindMed
Illumina Gets FDA Approval for Cancer Biomarker Test
Marketwatch
Tue, 08/27/24 - 11:14 am
Illumina
FDA
Medtech
TruSight Oncology
cancer
diagnostics
FDA seeks feedback on predetermined change control plans
Medtech Dive
Mon, 08/26/24 - 10:34 pm
FDA
Medtech
PCCPs
regulatory
devices
After FDA rejection, Regeneron gains nod in Europe for T-cell engager odronextamab
Fierce Pharma
Mon, 08/26/24 - 11:20 am
Regeneron
Europe
FDA
Ordspono
bispecifics
T-cell engager
Galapagos Surges On An FDA Win For Its Rival To Gilead, Novartis; But There Are Some Caveats
Investors Business Daily
Mon, 08/26/24 - 11:11 am
Galapagos
CAR-T
FDA
non-Hodgkin lymphoma
Gilead Sciences
Novartis
FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds
Fierce Pharma
Fri, 08/23/24 - 10:55 am
FDA
stomach cancer
Bristol Myers Squibb
Opdivo
Yervoy
Merck
Keytruda
BeiGene
Tevimbra
Updated COVID shots from Pfizer, Moderna cleared by FDA
BioPharma Dive
Thu, 08/22/24 - 10:03 pm
COVID-19
vaccines
Pfizer
Moderna Therapeutics
FDA
Gilead’s Livdelzi (Seladelpar) for Primary Biliary Cholangitis Promises Pruritus Reduction
Xtalks
Thu, 08/22/24 - 10:00 pm
FDA
Livdelzi
Gilead Sciences
primary biliary cholangitis
A First for Hypoparathyroidism — Yorvipath (Palopegteriparatide) Earns FDA Nod
Xtalks
Thu, 08/22/24 - 09:51 pm
Yorvipath
FDA
hypoparathyroidism
Ascendis Pharma
Updated COVID vaccines are coming soon
NPR
Thu, 08/22/24 - 11:20 am
FDA
COVID-19
vaccines
First bispecific CAR-T therapy for MS receives green light from FDA to start phase 1
Biopharma Reporter
Thu, 08/22/24 - 11:15 am
ImmPACT Bio
CAR-T
MS
multiple sclerosis
FDA
clinical trials
BMS eyes April FDA verdict on Opdivo/Yervoy in liver cancer
Pharmaphorum
Thu, 08/22/24 - 11:09 am
Bristol Myers Squibb
Opdivo
Yervoy
liver cancer
FDA
FDA’s plan to expand device surveillance faces challenges, GAO finds
Medtech Dive
Wed, 08/21/24 - 10:30 pm
FDA
regulatory
GAO
medtehc
devices
Pharma’s concerns pile up months after Supreme Court’s landmark Chevron decision
Pharma Voice
Wed, 08/21/24 - 11:18 am
Supreme Court
Chevron Doctrine
FDA
CMS
Inflation Reduction Act
Lawmakers urge FDA to investigate clinical trials run in tandem with China's military
Fierce Pharma
Tue, 08/20/24 - 10:06 pm
FDA
China
clinical trials
Biosecure Act
FDA declines to approve Regeneron's blood cancer therapy
Reuters
Tue, 08/20/24 - 09:59 pm
Regeneron
FDA
linvoseltamab
Multiple Myeloma

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