FDA

FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use
Medtech Dive
Fri, 06/30/23 - 10:08 am
Medtech
NuVasive
Precice Limb Lengthening System
FDA
FDA's Pazdur, sector leaders push for private-public partnership to boost DEI in cancer drug development
Fierce Biotech
Thu, 06/29/23 - 11:06 pm
FDA
cancer
diversity
BioMarin's hemophilia gene therapy Roctavian lands FDA nod with 'glimmers' of enthusiasm among doctors
Fierce Pharma
Thu, 06/29/23 - 10:56 pm
BioMarin Pharmaceuticall
Roctavian
FDA
hemophilia A
gene therapy
FDA Advisory Committee Recommends Ipsen's Palovarotene as an Effective and Safe Treatment for FOP
Globe Newswire
Wed, 06/28/23 - 10:27 pm
FDA
Ipsen
palovarotene
FOP
fibrodysplasia ossificans progressiva
10 clinical trials to watch in the second half of 2023
BioPharma Dive
Wed, 06/28/23 - 11:44 am
FDA
clinical trials
Sarepta Therapeutics
Bridge Bio
Sanofi
Merck KGaA
Pfizer
Novo Nordisk
Verve Therapeutics
Roche
Vertex Pharmaceuticals
JNJ
Bristol Myers Squibb
ATTR-CM
Elevidys
tolebrutinib
evobrutinib
danuglipron
tiragolumab
VX-548
lazertinib
Pfizer-OPKO's growth hormone drug gets US approval in kids
Yahoo/Reuters
Wed, 06/28/23 - 10:04 am
Pfizer
OPKO Health
FDA
pediatric
growth hormone deficiency
Ngenla
Regeneron's high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups
Fierce Pharma
Tue, 06/27/23 - 10:24 pm
Regeneron
Eylea
FDA
FDA Focuses on Modernizing Clinical Trials
Medical Devices and Diagnostics Industry
Tue, 06/27/23 - 10:19 pm
FDA
clinical trials
digital health
Jazz Pharma sues FDA over approval of rival narcolepsy drug
Medical Marketing and Media
Tue, 06/27/23 - 11:29 am
Jazz Pharma
FDA
Xyrem
Avadel Pharma
Lumryz
legal
UCB stakes claim to gMG market as FDA clears Rystiggo
Pharmaphorum
Tue, 06/27/23 - 11:21 am
UCB Pharma
Rystiggo
myasthenia gravis
FDA
FDA Warms Up to Ipsen’s Post-Hoc Analysis for Rare Disease Drug Ahead of Adcomm
BioSpace
Tue, 06/27/23 - 10:19 am
Ipsen
FDA
palovarotene
fibrodysplasia ossificans progressiva
Pfizer's Litfulo Scores FDA Approval As First Alopecia Treatment For Adolescents
Yahoo/Benzinga
Tue, 06/27/23 - 10:15 am
Pfizer
FDA
Litfulo
alopecia areata
5 FDA decisions to watch in the third quarter
BioPharma Dive
Mon, 06/26/23 - 10:04 am
FDA
SAGE Therapeutics
Biogen
zuranolone
Eisai
Leqembi
Sanofi
AstraZeneca
nirsevimab
Iveric Bio
Zimura
Alnylam
Onpattro
Surmodics and Abbott’s Drug-Coated Balloon for Peripheral Artery Disease Gets FDA Approval
Xtalks
Mon, 06/26/23 - 09:49 am
Medtech
SurModics
Abbott Labs
peripheral artery disease
FDA
SurVeil
drug-coated balloons
FDA discloses its first draft guidance on psychedelic trials
Clinical Trials Arena
Mon, 06/26/23 - 09:47 am
FDA
clinical trials
psychedelics
Jazz brings the noise to the FDA with lawsuit over approval of Avadel's narcolepsy drug Lumryz
Fierce Pharma
Sun, 06/25/23 - 09:41 pm
Jazz Pharmaceuticals
FDA
legal
Avadel Pharmaceuticals
Lumryz
Xyrem
Is This a Sign That Biogen's Leqembi Could Obtain FDA Approval Next Month?
Motley Fool
Fri, 06/23/23 - 10:03 am
Biogen
Eisai
Alzheimer's disease
FDA
Leqembi
FDA Approves Sarepta’s Gene Therapy for Duchenne Muscular Dystrophy
BioSpace
Thu, 06/22/23 - 10:51 pm
Sarepta Therapeutics
DMD
Duchenne Muscular Dystrophy
FDA
Elevidys
gene therapy
Intercept restructures as Ocaliva's NASH hopes dashed again with FDA rejection
Fierce Pharma
Thu, 06/22/23 - 10:46 pm
Intercept Pharma
NASH
Ocaliva
obeticholic acid
FDA
Moderna Files for FDA Authorization of Its Updated COVID-19 Vaccine
BioSpace
Thu, 06/22/23 - 10:39 pm
Moderna Therapeutics
vaccines
COVID-19
FDA

Pages