FDA

Market for CAR-Ts Still Bright Despite FDA Cancer Safety Review
BioSpace
Wed, 12/20/23 - 09:36 am
CAR-T
FDA
cancer
FDA accepts Merck’s pneumococcal vaccine BLA for priority review
Pharmaceutical Technology
Wed, 12/20/23 - 09:34 am
Merck
vaccines
FDA
pneumococcal disease
V116
FDA approves first test to identify opioid use addiction risk
Reuters
Wed, 12/20/23 - 09:26 am
AvertD
Medtech
diagnostics
SOLVD Health
FDA
opioid addiction
opioids
FDA Facing Increased Scrutiny Over Medical Device Recalls
Medical Devices and Diagnostics Industry
Tue, 12/19/23 - 11:17 pm
FDA
Medtech
device recalls
Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval
MedCity News
Tue, 12/19/23 - 11:13 pm
Chiesi
Filsuvez
FDA
epidermolysis bullosa
Roche, Novartis move Xolair closer to FDA finish line for food allergies
Fierce Pharma
Tue, 12/19/23 - 11:10 pm
Roche
FDA
Xolair
food allergies
Novartis
FDA approves safety labeling changes for opioids
Pharmacist.com
Mon, 12/18/23 - 10:07 pm
FDA
labeling
opioids
FDA Finds Quality Control Problems at Moderna’s Vaccine Facility: Reuters
BioSpace
Mon, 12/18/23 - 10:18 am
Moderna Therapeutics
vaccines
drug manufacturing
FDA
Oncologists Defend CAR-T After FDA Advisory
BioSpace
Mon, 12/18/23 - 10:11 am
oncologists
CAR-T
cancer
FDA
House lawmakers threaten FDA with subpoena amid probe into overseas inspections
Fierce Pharma
Sun, 12/17/23 - 09:55 pm
FDA
regulatory
foreign inspections
Glaukos eye implant swings FDA approval
Clinical Trials Arena
Sun, 12/17/23 - 09:51 pm
Glaukos
FDA
ocular hypertension
iDose
FDA Puts Clinical Hold on Three CARsgen Therapeutics CAR-T Candidates
BioSpace
Fri, 12/15/23 - 11:14 am
CARsgen
FDA
cell therapy
CAR-T
US WorldMeds' Iwilfin bags FDA nod as 1st oral maintenance treatment for high-risk neuroblastoma
Fierce Pharma
Thu, 12/14/23 - 10:52 pm
US WorldMeds
Iwilfin
FDA
neuroblastoma
First-ever drug application for MDMA finally reaches FDA after near 40-year journey
Fierce Biotech
Thu, 12/14/23 - 09:51 am
FDA
MDMA
psychedelics
Candel (CADL) Rises on FDA's Fast Track Status for CAN-2409
Yahoo/Zacks.com
Thu, 12/14/23 - 09:36 am
Candel Therapeutics
FDA
fast track
CAN-2409
pancreatic cancer
FDA approves Medtronic's system for heart condition
Reuters
Wed, 12/13/23 - 10:05 pm
Medtech
Medtronic
FDA
PulseSelect
pulsed field ablation
atrial fibrillation
FDA Creates Adcomm for Genetic Metabolic Diseases and Potential Treatments
BioSpace
Wed, 12/13/23 - 09:34 am
FDA
advisory committees
genetic metabolic diseases
regulatory
US consumer group seeks stronger warnings on Botox, similar treatments
Reuters
Tue, 12/12/23 - 10:02 am
Public Citizen
FDA
Botox
AbbVie
Revance Therapeutics
Daxxify
Evolus
Jeuveau
Supernus Pharmaceuticals
Myobloc
Galderma
Dysport
ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy
Fierce Pharma
Mon, 12/11/23 - 10:55 pm
ASH 2023
Abecma
FDA
CAR-T
Bristol Myers Squibb
Novartis gears up for label expansion for Kisqali with Phase III results
Clinical Trials Arena
Mon, 12/11/23 - 11:18 am
Novartis
Kisqali
FDA
clinical trials
early breast cancer
breast cancer

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