FDA

Rapport's attempt to test epilepsy drug in nerve damage placed on hold by FDA
Fierce Biotech
Thu, 11/7/24 - 11:32 am
Rapport Therapeutics
clinical trials
RAP-219
FDA
diabetic peripheral neuropathy
With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC
BioPharma Dive
Thu, 11/7/24 - 11:30 am
Donald Trump
biotech
FTC
FDA
Robert F Kennedy Jr.
FDA adds aspiration warning to Ozempic, Mounjaro and other GLP-1 labels
Beckers Hospital Review
Wed, 11/6/24 - 08:01 pm
FDA
warnings
aspiration
Ozempic
Wegovy
Saxenda
Mounjaro
Novo Nordisk
Eli Lilly
A diabetes drug, twice rejected, stumbles again — but its developer persists
Pharma Voice
Wed, 11/6/24 - 11:31 am
Lexicon Pharmaceuticals
FDA
type 1 diabetes
sotagliflozin
FDA delays decision on Merus' first-in-class cancer drug by 3 months
Fierce Biotech
Tue, 11/5/24 - 10:03 am
Merus
FDA
solid tumors
zenocutuzumab
Disc maps out US filing for porphyria drug bitopertin
Pharmaphorum
Tue, 11/5/24 - 10:00 am
Disc Medicine
porphyria
bitopertin
FDA
Journey slips on FDA approval of rosacea therapy
Pharmaphorum
Tue, 11/5/24 - 09:59 am
Journey Medical
FDA
Emrosi
Rosacea
Pharma 'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says
Fierce Pharma
Fri, 11/1/24 - 11:14 am
FDA
CAR-T
black box
Peter Marks
Lexicon's type 1 diabetes drug voted down by FDA adcomm
Pharmaphorum
Fri, 11/1/24 - 10:58 am
Lexicon Pharmaceuticals
Zynquista
FDA
type 1 diabetes
Eisai, Biogen eye 2025 approval for Leqembi autoinjector
Pharmaphorum
Fri, 11/1/24 - 10:57 am
Eisai
Biogen
Leqembi
Alzheimer's disease
FDA
FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.
BioPharma Dive
Thu, 10/31/24 - 10:43 pm
FDA
devices
Medtech
patients
patient advocacy groups
Novartis gets FDA okay for frontline use of Scemblix in CML
Pharmaphorum
Wed, 10/30/24 - 11:38 am
Novartis
CML
Scemblix
FDA
Lexicon's revised Zynquista bid in type 1 diabetes faces lingering safety questions
First Word Pharma
Tue, 10/29/24 - 08:07 pm
Lexicon Pharmaceuticals
type 1 diabetes
Zynquista
FDA
Dueling IL-23 data drop as Lilly, J&J await FDA decisions in Crohn's
First Word Pharma
Mon, 10/28/24 - 06:24 pm
Eli Lilly
JNJ
Crohn's Disease
FDA
clinical trials
Tremfya
Omvoh
After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah
Fierce Pharma
Sun, 10/27/24 - 07:48 pm
Iterum
antibiotics
UTIs
FDA
Orlynvah
GSK answers Pfizer's RSV approval with data targeting matching nod in younger adults
Fierce Pharma
Thu, 10/24/24 - 10:58 am
GSK
Arexvy
vaccines
RSV
Pfizer
FDA
FDA’s GLP-1 decision kicks off ‘unprecedented’ tussle over shortage
BioPharma Dive
Wed, 10/23/24 - 11:40 am
FDA
GLP-1 agonists
drug shortages
compounding pharmacies
Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package
Fierce Biotech
Wed, 10/23/24 - 11:33 am
Sangamo Therapeutics
Fabry disease
FDA
ST-920
FDA names Tarver as new head of device center
Biopharma Reporter
Tue, 10/22/24 - 11:26 pm
Medtech
FDA
devices
Michelle Tarver
CDRH
Adcentrx gets FDA clearance for phase 1 trial of ADC for tumors
Biopharma Reporter
Tue, 10/22/24 - 11:31 am
Adcentrx
solid tumors
clinical trials
FDA
ADRX-0405

Pages