FDA

BridgeBio gears up for FDA review of acoramidis following Phase III results
Clinical Trials Arena
Thu, 01/11/24 - 11:07 am
BridgeBio
FDA
acoramidis
clinical trials
FDA’s CAR T Probe ‘Not a Big Deal’ for Oncology-Focused Biotechs: Triumvira President
BioSpace
Wed, 01/10/24 - 06:25 pm
oncology
CAR-T
regulatory
FDA
FDA Pushes Back On Calls For Safety Tests Of Generic Drugs
Forbes
Wed, 01/10/24 - 06:23 pm
FDA
drug safety
generics
Alcon’s dry eye drug achieves primary endpoints in Phase III trials
Clinical Trials Arena
Wed, 01/10/24 - 09:42 am
Alcon
dry eye disease
FDA
clinical trials
AR-15512
Gene Therapy Approvals Expected to Ramp Up in 2024 Amid Manufacturing, Cost Challenges
BioSpace
Tue, 01/9/24 - 10:24 am
gene therapy
cell therapy
FDA
FDA declines to approve Astellas' gastric cancer drug
Reuters
Tue, 01/9/24 - 09:39 am
Astellas
FDA
gastric cancer
zolbetuximab
An unusual drugmaker raises north of $100M for ecstasy-based PTSD therapy
BioPharma Dive
Sun, 01/7/24 - 04:06 pm
Lykos Therapeutics
MDMA
FDA
funding
FDA to allow Florida to import cheaper drugs from Canada
Reuters
Fri, 01/5/24 - 09:52 am
FDA
Canada
Florida
drug importation
FDA warns providers not to buy or implant Synovo’s total hip system
Medtech Dive
Thu, 01/4/24 - 11:39 am
Synovo
Medtech
FDA
femoral resurfacing cups
hip replacements
GAO Urges FDA, CISA to Update Medical Device Cybersecurity Guidance
Medical Devices and Diagnostics Industry
Wed, 01/3/24 - 09:31 am
Medtech
cybersecurity
FDA
CISA
devices
GAO
FDA ends busy year with three drug rejections
BioPharma Dive
Tue, 01/2/24 - 10:13 pm
FDA
Amgen
Zealand Pharma
Merck
Glaukos Wins FDA Nod for Glaucoma Treatment Implant
Medical Devices and Diagnostics Industry
Tue, 01/2/24 - 10:06 pm
Glaukos
glaucoma
Medtech
ocular hypertension
FDA
5 FDA Decisions to Watch in Q1
BioSpace
Tue, 01/2/24 - 11:24 am
FDA
Iovance Biotherapeutics
melanoma
lifileucel
Minerva Neurosciences
schizophrenia
roluperidone
Viatris
Mapi Pharma
MS
multiple sclerosis
GA Depot
Madrigal Pharmaceuticals
NASH
resmetirom
Vertex Pharmaceuticals
CRISPR Therapeutics
exa-cel
beta thalassemia
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
Fierce Pharma
Tue, 01/2/24 - 10:10 am
FDA
drug approvals
Pfizer
COVID-19
Iovance Plummets as FDA Halts Cancer Drug Trial After Death
Yahoo/Bloomberg
Sun, 12/31/23 - 11:54 am
Iovance Biotherapeutics
FDA
lung cancer
clinical trials
Amgen's request for full approval of Lumakras in lung cancer denied by FDA
Fierce Pharma
Wed, 12/27/23 - 11:02 pm
Amgen
Lumakras
FDA
non-small cell lung cancer
FDA grants priority review for Daiichi Sankyo-Merck’s lung cancer therapy
Pharmaceutical Business Review
Wed, 12/27/23 - 11:00 pm
Daiichi Sankyo
Merkc
patritumab deruxtecan
FDA
non-small cell lung cancer
FDA approves Ionis-AstraZeneca's nerve disease drug
Reuters
Fri, 12/22/23 - 09:42 am
Ionis Pharmaceuticals
AstraZeneca
FDA
Wainua
ATTR-PN
FDA warns about counterfeit versions of Novo's diabetes drug Ozempic
Reuters
Fri, 12/22/23 - 09:40 am
Novo Nordisk
FDA
Ozempic
diabetes
drug counterfeiting
Merck’s Chronic Cough Drug Fails to Secure FDA Approval for Second Time
BioSpace
Thu, 12/21/23 - 11:36 am
Merck
gefapixant
chronic cough
FDA

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