FDA

FDA commissioner pledges to investigate mifepristone
The Hill
Tue, 06/3/25 - 11:01 pm
FDA
Marty Makary
abortion pill
mifepristone
Amid staff cuts, FDA looks to AI to 'optimize' reviews
Pharmaphorum
Tue, 06/3/25 - 10:38 am
FDA
artificial intelligence
genAI
drug reviews
Clairity Breast Becomes First FDA-Authorized AI to Predict Breast Cancer Using Mammograms
Xtalks
Tue, 06/3/25 - 10:36 am
Clairity
Clairity Breast
breast cancer
FDA
Medtech
artificial intelligence
mammograms
Trump administration proposes cutting FDA budget by 5.5%
MSN/Reuters
Mon, 06/2/25 - 11:47 pm
FDA
user fees
Donald Trump
Marty Makary
Moderna's next-gen COVID shot gets FDA backing with some limitations
Fierce Pharma
Mon, 06/2/25 - 11:30 am
Moderna Therapeutics
FDA
COVID-19
vaccines
mNEXSPIKE
AbbVie’s ADC win shows how pharma can break through in solid tumors
Pharma Voice
Fri, 05/30/25 - 11:09 am
AbbVie
antibody-drug conjugates
solid tumors
FDA
Emrelis
Optive AI Gets FDA Clearance, Elevates Image Quality for Swoop Portable MRI
Xtalks
Thu, 05/29/25 - 07:08 pm
Medtech
Optive AI
Hyperfine
brain imaging
FDA
Boston Scientific pulls plug on TAVR devices after failing to gain FDA approval
Cardiovascular Business
Thu, 05/29/25 - 11:15 am
Medtech
Boston Scientific
Acurate Neo 2
Acurate Prime
TAVR
FDA
Stealth hit by FDA rejection to twice-delayed filing as it lays off staff
Fierce Biotech
Thu, 05/29/25 - 11:08 am
Stealth BioTherapeutics
layoffs
FDA
Rare Diseases
FDA approves Alcon’s Tryptyr (AR-15512) for signs and symptoms of dry eye disease
Ophthalmology Times
Thu, 05/29/25 - 11:00 am
Alcon
FDA
Tryptyr
dry eye disease
Merck and Daiichi Sankyo pull HER3-DXd's FDA filing
Pharmaphorum
Thu, 05/29/25 - 10:33 am
Merck
Daiichi Sankyo
patritumab deruxtecan
HER3-DXd
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FDA Outlines AI Medical Device Software Recommendations in Draft Guidance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

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