FDA

FDA Approves UTILITY’s New Antibiotic for Uncomplicated UTI in Women
BioSpace
Thu, 04/25/24 - 11:37 am
UTILITY Therapeutics
FDA
pivmecillinam
Pivya
UTIs
Day One’s Ojemda Gets FDA Accelerated Approval for Pediatric Brain Tumor
BioSpace
Wed, 04/24/24 - 08:46 am
Day One Biopharmaceuticals
FDA
tovorafenib
Ojemda
pediatric
brain tumors
pediatric low-grade glioma
Exactech recalls shoulder devices after initially declining to act
Medtech Dive
Tue, 04/23/24 - 10:41 am
Medtech
Exactech
shoulder implants
device recalls
FDA
ImmunityBio bags FDA approval for Anktiva to challenge Merck in bladder cancer
Fierce Pharma
Tue, 04/23/24 - 10:32 am
ImmunityBio
immunotherapy
FDA
anktiva
Patrick Soon-Shiong
Breast Cancer Detection Drug-Device System Nabs FDA Approval
Medical Devices and Diagnostics Industry
Mon, 04/22/24 - 05:51 pm
Medtech
Lumicell
FDA
Limisight
optical imaging
breast cancer
diagnostics
Roche wins FDA OK for targeted drug in early lung cancer
BioPharma Dive
Fri, 04/19/24 - 11:40 am
Roche
Alecensa
ALK inhibitors
FDA
non-small cell lung cancer
FDA mandates label updates on CAR-T cancer therapies
Reuters
Thu, 04/18/24 - 10:34 pm
CAR-T
FDA
warning
cancer
Gilead Sciences
Bristol Myers Squibb
2seventybio
Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation
Xtalks
Thu, 04/18/24 - 10:28 pm
Roche
FDA
Medtech
Eli Lilly
Elecsys pTau217
Alzheimer's disease
diagnostics
FDA fast-tracks AskBio’s heart failure gene therapy
Pharmaphorum
Thu, 04/18/24 - 11:14 am
FDA
Bayer
AskBio
heart failure
gene therapy
fast track
AB-1002
Vertex inches closer to acute pain market with FDA application acceptance
Fierce Biotech
Thu, 04/18/24 - 11:10 am
Vertex Pharmaceuticals
VX-548
acute pain
painkillers
FDA
non-opioid pain treatments
Lilly Alzheimer's med glides out of Leqembi's slipstream with FDA adcomm request
Fierce Biotech
Wed, 04/17/24 - 09:58 pm
Eli Lilly
donanemab
Alzheimer's disease
Leqembi
Biogen
Eisai
FDA
Removing the Misconceptions Surrounding Biosimilar Interchangeability
Center for Biosimilars
Tue, 04/16/24 - 07:41 am
FDA
interchangeability
biosimilars
GSK trails after Pfizer in 5-in-1 meningococcal vaccine race
Pharmaphorum
Tue, 04/16/24 - 07:35 am
GSK
meningococcal disease
Pfizer
vaccines
FDA
Bexero
Menveo
FDA establishes CDER Center for Clinical Trial Innovation
FDA
Mon, 04/15/24 - 09:33 pm
FDA
CDER
clinical trials
clinical trial innovation
Novartis touts surrogate endpoint win, nabs priority review for Fabhalta in IgAN
Fierce Pharma
Mon, 04/15/24 - 09:32 pm
Novartis
Fabhalta
IgAN
priority review
FDA
Neumora's schizophrenia drug faces FDA hold over convulsions in rabbits
Fierce Biotech
Mon, 04/15/24 - 11:00 am
Neumora Therapeutics
schizophrenia
FDA
clinical trials
NMRA-266
Candel wins FDA orphan drug designation for pancreatic cancer drug
Clinical Trials Arena
Sun, 04/14/24 - 01:23 pm
FDA
Candel Therapeutics
CAN-2409
pancreatic cancer
orphan drugs
AstraZeneca Expands Fasenra’s Label to Younger Children with Severe Asthma
BioSpace
Fri, 04/12/24 - 11:15 am
AstraZeneca
Fasenra
severe asthma
FDA
eosinophilic asthma
pediatric
FDA commissioner tells lawmakers his agency needs more authority to prevent drug shortages
Fierce Pharma
Fri, 04/12/24 - 11:12 am
FDA
Robert Califf
drug shortages
FDA puts breakthrough tag on Roche, Lilly Alzheimer’s test
Pharmaphorum
Thu, 04/11/24 - 10:52 am
diagnostics
Roche
Eli Lilly
Alzheimer's disease
FDA
breakthrough designation

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