FDA

How might the FDA evolve under RFK Jr. and Makary?
BioSpace
Wed, 01/29/25 - 11:48 am
FDA
HHS
regulatory
Robert F Kennedy Jr.
Marty Makary
FDA approves new indication for Ozempic to lower kidney risks in type 2 diabetes, CKD
Healio
Tue, 01/28/25 - 09:42 pm
Novo Nordisk
FDA
Ozempic
kidney disease
Enhertu, with new FDA OK, set to supplant chemo in HER2-low breast cancer
BioPharma Dive
Tue, 01/28/25 - 10:40 am
AstraZeneca
Daiichi Sankyo
Enhertu
HER2-low breast cancer
FDA
Biogen, Eisai Win Nod for Monthly Leqembi Maintenance Amid Stagnant Sales
BioPharma Dive
Mon, 01/27/25 - 11:24 am
Biogen
Eisai
Leqembi
Alzheimer's disease
FDA
Sara Brenner, FDA device official, named agency’s acting head
BioPharma Dive
Mon, 01/27/25 - 11:18 am
FDA
Sara Brenner
Donald Trump
regulatory
The FDA pulls key DEI initiative for cancer studies from its website
NPR
Sun, 01/26/25 - 04:06 pm
FDA
clinical trial diversity
clinical trials
cancer
AI in medtech is taking off. Here are 4 trends to watch in 2025.
BioPharma Dive
Thu, 01/23/25 - 11:50 am
artificial intelligence
AI
Medtech
FDA
hospitals
FDA Tacks Boxed Warning on Teva’s Copaxone, Other MS Drugs
BioSpace
Thu, 01/23/25 - 11:44 am
Teva Pharmaceutical
black box
MS
multiple sclerosis
FDA
anaphylaxis
Navigating FDA’s Draft Guidance for AI-Enabled Medical Devices
Medical Devices and Diagnostics Industry
Thu, 01/23/25 - 11:37 am
Medtech
artificial intelligence
AI-enabled devices
FDA
regulatory
Trump admin orders federal health agencies to halt communications
Axios
Wed, 01/22/25 - 11:48 am
Donald Trump
Public Health
CDC
HHS
FDA
NIH
Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs
Fierce Pharma
Tue, 01/21/25 - 07:08 pm
Sanofi
drug manufacturing
FDA
Genzyme
Massachusetts
FDA approves Johnson & Johnson’s nasal spray for depression as standalone treatment
CNBC
Tue, 01/21/25 - 11:34 am
JNJ
FDA
major depressive disorder
Spravato
ketamine
FDA gives Amylyx green light for phase 1 ALS trial after clinical hold
Fierce Biotech
Tue, 01/21/25 - 11:23 am
Amylyx
ALS
FDA
AMX0114
clinical trials
FDA Approves Amgen's Groundbreaking LUMAKRAS Combination Therapy for Colorectal Cancer Treatment
Stock Titan
Fri, 01/17/25 - 11:21 am
Amgen
FDA
Lumakras
Vectibix
metastatic colorectal cancer
HER-positive colorectal cancer
AstraZeneca gets full FDA approval for CMS-selected lymphoma treatment
BioSpace
Fri, 01/17/25 - 11:15 am
AstraZeneca
Calquence
mantle cell lymphoma
FDA
After Letter to Commissioner, FDA Finally Gives Vanda Reason for Rejection, Chance for Hearing
BioSpace
Thu, 01/16/25 - 11:21 am
FDA
Robert Califf
Vanda Pharmaceuticals
tradipitant
Qiagen Receives FDA Clearance for First Mini Gastrointestinal Panel
Xtalks
Thu, 01/16/25 - 11:15 am
Qiagen
Medtech
diagnostics
FDA
gastrointestinal disease
Lilly's Omvoh scores second IBD win with FDA nod in Crohn's
First Word Pharma
Wed, 01/15/25 - 11:50 pm
Eli Lilly
Omvoh
IBD
FDA
Crohn's Disease
Federal watchdog cites concerns with FDA’s accelerated approval process
BioPharma Dive
Wed, 01/15/25 - 11:48 pm
HHS
FDA
accelerated approvals
Aduhelm
Biogen
Medtech Implementation of FDA’s Updated QMSR
Medical Devices and Diagnostics Industry
Tue, 01/14/25 - 11:16 am
Medtech
FDA
regulatory
QMSR

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