FDA

FDA approves use of Sanofi's meningococcal vaccine in infants
MSN/Reuters
Wed, 05/28/25 - 09:52 am
Sanofi
FDA
vaccines
meningococcal disease
infants
MenQuadfi
FDA fast-tracks Teva's celiac disease treatment
Pharmaphorum
Wed, 05/28/25 - 09:35 am
Teva Pharmaceutical
FDA
celiac disease
fast track status
FDA sets COVID vaccine formula as RFK Jr. narrows guidance for shots
BioPharma Dive
Tue, 05/27/25 - 10:16 pm
FDA
HHS
Robert F Kennedy Jr.
vaccines
COVID-19
Abbott Celebrates Huge Win in TMVR Space
Medical Devices and Diagnostics Industry
Tue, 05/27/25 - 10:10 pm
Medtech
Abbott Labs
FDA
Tendyne
TMVR
Edwards Lifesciences
Sapien 3
FDA Outlines AI Medical Device Software Recommendations in Draft Guidance
Medical Devices and Diagnostics Industry
Tue, 05/27/25 - 11:37 am
FDA
regulatory
artificial intelligence
Medtech
Rocket crashes as gene therapy patient dies, FDA imposes hold
Fierce Biotech
Tue, 05/27/25 - 11:35 am
Rocket Pharmaceuticals
gene therapy
patient death
FDA
Danon disease
Navigating the FDA’s accelerated approval pathways for oncology drugs
Clinical Trials Arena
Fri, 05/23/25 - 08:48 am
FDA
oncology
cancer
accelerated approvals
GSK’s Nucala wins U.S. nod as first IL-5 biologic for COPD
Drug Discovery and Development
Thu, 05/22/25 - 09:25 pm
GSK
Nucala
COPD
FDA
Vaccine advisers to the FDA recommended changes to COVID vaccines
NPR
Thu, 05/22/25 - 09:17 pm
COVID-19
vaccines
FDA
FDA proposes FY 2026 budget; Makary offers details on staff attrition
RAPS.org
Thu, 05/22/25 - 09:15 pm
FDA
regulatory
Marty Makary
FDA advisors unanimously snub Pfizer's Talzenna in broader prostate cancer population
Fierce Pharma
Thu, 05/22/25 - 11:27 am
Pfizer
FDA
adcomm
Talzenna
prostate cancer
FDA clears Grifols’ application for dry eye disease treatment
Clinical Trials Arena
Thu, 05/22/25 - 11:08 am
FDA
Grifols
dry eye disease
FDA expands warnings of heart risks on COVID shots
Axios
Wed, 05/21/25 - 10:39 pm
Pfizer
Moderna Therapeutics
FDA
vaccines
myocarditis
COVID-19
FDA Advisory Committee finds evidence for UGN-102 inconclusive, cites uncertainty in benefit-risk
Urology Times
Wed, 05/21/25 - 10:32 pm
Urogen
UGN-102
non-muscle invasive bladder cancer
FDA
ODAC
FDA offering states help for Canada drug importation proposals
Seeking Alpha
Wed, 05/21/25 - 10:26 pm
FDA
Canada
drug importation
J&J's Darzalex wins FDA advisors' backing as potential first treatment for smoldering myeloma
Fierce Pharma
Wed, 05/21/25 - 11:33 am
JNJ
Darzalex
Multiple Myeloma
FDA
A stricter FDA policy for COVID vaccines could limit future access
NPR
Wed, 05/21/25 - 11:18 am
FDA
COVID-19
vaccines
Roche's Columvi expansion bid in danger as FDA's Martin Makary, Richard Pazdur push for more US enrollment in cancer trials
Fierce Pharma
Tue, 05/20/25 - 09:44 pm
Roche
DLBCL
Columvi
FDA
clinical trials
FDA outlines stricter Covid vaccine booster approval standards for healthy people
CNBC
Tue, 05/20/25 - 11:29 am
FDA
COVID-19
boosters
vaccines
clinical trials
FDA grants clearance to BrainStorm’s Phase IIIb trial of ALS treatment
Clinical Trials Arena
Tue, 05/20/25 - 10:19 am
FDA
BrainStorm Cell Therapeutics
clinical trials
NurOwn
ALS

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