FDA

Merck’s next big thing is (probably) on the way
Stat
Tue, 03/26/24 - 11:03 am
Merck
FDA
sotatercept
PAH
US lawmaker seeks answers on FDA inspection of Musk's Neuralink
Reuters
Tue, 03/26/24 - 11:00 am
Neuralink
Elon Musk
FDA
brain implants
Nanoscope eyes market after gene therapy restores vision for patients with retinal disease
Fierce Biotech
Tue, 03/26/24 - 10:53 am
Nanoscope Therapeutics
gene therapy
FDA
FDA blocks approval of Regeneron's blood cancer drug over confirmatory trial enrollment
Fierce Biotech
Mon, 03/25/24 - 11:27 am
Regeneron
FDA
odronextamab
clinical trials
blood cancers
J&J Wins FDA Nod for Pulmonary Arterial Hypertension Combo Pill
BioSpace
Mon, 03/25/24 - 11:24 am
JNJ
FDA
PAH
Opsynvi
macitentan
tadalafil
Esperion Targets Seven-Fold Jump in Cholesterol Drug Population with FDA Label Expansion
BioSpace
Mon, 03/25/24 - 11:19 am
Esperion Therapeutics
cholesterol
Nexletol
Nexlizet
FDA
FDA authorizes new drug to protect immune compromised from Covid-19
Stat
Sun, 03/24/24 - 10:35 pm
Invivyd
Pemgarda
FDA
COVID-19
FDA’s updated RWE guidelines allow pharma marketers to make more claims
Medical Marketing and Media
Sun, 03/24/24 - 10:27 pm
FDA
RWE
real world evidence
product claims
How Will FDA’s New QMSR Affect Medical Device Companies?
Medical Devices and Diagnostics Industry
Sun, 03/24/24 - 10:23 pm
Medtech
devices
FDA
QMSR
FDA approves Italfarmaco’s Duvyzat for DMD treatment
Pharmaceutical Business Review
Fri, 03/22/24 - 09:38 am
Italfarmaco
FDA
Duvyzat
DMD
Duchenne Muscular Dystrophy
Idorsia's Tryvio crosses FDA finish line, offering new mechanism to treat hypertension
Fierce Pharma
Wed, 03/20/24 - 09:49 pm
JNJ
Idorsia
Tryvio
hypertension
FDA
[podcast]Brukinsa approval raises BeiGene’s hematology profile
Medical Marketing and Media
Wed, 03/20/24 - 09:38 pm
BeiGene
Brukinsa
FDA
hematology
FDA unveils comprehensive strategy for regulating AI in medical products
Biopharma Reporter
Wed, 03/20/24 - 11:27 am
FDA
artificial intelligence
FDA Approves Iclusig for New Patients with Aggressive Leukemia
Managed Healthcare Executive
Tue, 03/19/24 - 09:20 pm
Takeda
Iclusig
FDA
acute lymphoblastic leukemia
After Kyowa Kirin buyout, Orchard scores FDA approval for first MLD gene therapy in the US
Fierce Pharma
Mon, 03/18/24 - 05:16 pm
Orchard Therapeutics
Kyowa Kirin
M&A
Lenmeldy
FDA
metachromatic leukodystrophy
Becoming ‘biologic-like’: CAR-T makers on quest to scale drugs’ production
Medical Marketing and Media
Mon, 03/18/24 - 05:13 pm
CAR-T
FDA
drug development
Despite early death concerns, FDA advisers back J&J and Legend's Carvykti and BMS' Abecma for earlier myeloma
Fierce Pharma
Sun, 03/17/24 - 09:30 pm
JNJ
Legend Biotech
CAR-T
FDA
Carvykti
Abecma
Not a Moment Too Soon: FDA Clears Intuitive Surgical's New Robot
Medical Devices and Diagnostics Industry
Sun, 03/17/24 - 09:23 pm
Medtech
FDA
Intuitive Surgical
da Vinci 5
robotic surgery
BMS’s Breyanzi Becomes First CAR-T Therapy for Two Types of Leukemia
BioSpace
Fri, 03/15/24 - 11:32 am
Bristol Myers Squibb
CAR-T
CLL
Breyanzi
FDA
JNJ
Carvykti
Madrigal wins FDA approval of first drug for MASH
BioPharma Dive
Thu, 03/14/24 - 06:27 pm
Madrigal Pharmaceuticals
FDA
Rezdiffra
MASH
NASH

Pages