FDA

UCB rapidly bolsters blockbuster potential for Bimzelx with 3 new FDA approvals
Fierce Pharma
Mon, 09/23/24 - 10:19 pm
UCB Pharma
Bimzelx
FDA
psoriatic arthritis
radiographic axial spondyloarthritis
ankylosing spondylitis
FDA clears first drug for Niemann-Pick disease
Pharmaphorum
Mon, 09/23/24 - 09:47 am
Zevra Therapeutics
Miplyffa
FDA
Niemann-Pick disease
With FDA nod, AstraZeneca's FluMist becomes first self-administered flu vaccine
Fierce Pharma
Sun, 09/22/24 - 09:49 pm
AstraZeneca
FluMist
vaccines
FDA
Sanofi breaks into first-line multiple myeloma with FDA approval for Sarclisa
Fierce Pharma
Sun, 09/22/24 - 09:44 pm
Sanofi
Sarclisa
FDA
Multiple Myeloma
Sanofi’s eyes approval after MS therapy slows disease progression by 31%
Clinical Trials Arena
Sun, 09/22/24 - 09:42 pm
Sanofi
tolebrutinib
MS
multiple sclerosis
FDA
Vanda Contests FDA Rejection of Gastroparesis Drug, Slams ‘Delayed’ Decision
BioSpace
Fri, 09/20/24 - 11:23 am
Vanda Pharmaceuticals
FDA
gastroparesis
tradipitant
FDA approves Elanco's skin disease treatment for dogs
Reuters
Thu, 09/19/24 - 09:14 pm
animal health
Elanco
FDA
Vanda receives FDA rejection, issues fiery response against ‘conclusory’ refusal
Fierce Biotech
Thu, 09/19/24 - 09:29 am
Vanda Pharmaceuticals
FDA
gastroparesis
clinical trials
tradipitant
FDA inspection backlog overseas threatens new drug approvals
Pharma Voice
Thu, 09/19/24 - 09:23 am
FDA
regulatory inspections
regulatory
drug approvals
FDA Approves Merck’s Keytruda for First-Line Treatment of Pleural Mesothelioma
BioSpace
Wed, 09/18/24 - 11:16 pm
Merck
Keytruda
mesothelioma
FDA
FDA scraps adcomm for Applied's rare disease drug ahead of November decision
Fierce Biotech
Wed, 09/18/24 - 01:56 pm
Applied Therapeutics
govorestat
FDA
Rare Diseases
FDA lifts partial clinical hold on Zentalis Pharma’s cancer WEE1 inhibitor
Clinical Trials Arena
Wed, 09/18/24 - 11:56 am
Zentalis Pharmaceuticals
azenosertib
FDA
clinical trials
Musk's Neuralink gets FDA's breakthrough device tag for 'Blindsight' implant
Reuters
Tue, 09/17/24 - 11:10 pm
Neuralink
Elon Musk
FDA
Medtech
breakthrough devices
Blindsight
Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer
Fierce Pharma
Tue, 09/17/24 - 11:08 pm
Novartis
FDA
Eli Lilly
breast cancer
Kisqali
FDA designations boost AI-Driven cell therapy approach for Duchenne muscular dystrophy
Biopharma Reporter
Tue, 09/17/24 - 09:53 am
Somite
FDA
pediatrics
cell replacement therapy
artificial intelligence
DMD
Duchenne Muscular Dystrophy
FDA drafts guidance on multiregional clinical trials in oncology
RAPS.org
Mon, 09/16/24 - 10:24 pm
FDA
regulatory
clinical trials
MRCTs
oncology
FDA approves Eli Lilly's drug for eczema
Reuters
Mon, 09/16/24 - 10:16 pm
Eli Lilly
FDA
eczema
Ebgylss
Intercept's liver med Ocaliva takes heat at FDA expert meeting, as hopes for full approval dim
Fierce Pharma
Mon, 09/16/24 - 10:54 am
Intercept Pharma
Ocaliva
FDA
primary biliary cholangitis
ESMO: AstraZeneca stands by Truqap despite surprise breast cancer flop
Fierce Pharma
Fri, 09/13/24 - 11:00 am
AstraZeneca
ESMO
FDA
Truqap
FDA pushed to be more open, collaborative to accelerate rare disease R&D
Fierce Biotech
Fri, 09/13/24 - 09:43 am
FDA
innovation
Rare Diseases

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