FDA

PTC's plans crash into regulatory reality as FDA demands data on 2 candidates, delaying filing
Fierce Biotech
Fri, 10/27/23 - 11:49 am
PTC Therapeutics
FDA
Friedreich's Ataxia
FDA Approves Novel Corticosteroid Treatment Option for DMD Patients
BioSpace
Fri, 10/27/23 - 11:47 am
Santhera Pharmaceuticals
Catalyst Pharmaceuticals
Agamree
FDA
DMD
Duchenne Muscular Dystrophy
Alnylam Publishes Phase III ATTR-CM Data for Patisiran After FDA Rejection
BioSpace
Thu, 10/26/23 - 10:39 am
Alnylam
Patisiran
clinical trials
FDA
ATTR with cardiomyopathy
Servier’s Tibsovo Gets FDA Approval as First Targeted Therapy for MDS
BioSpace
Wed, 10/25/23 - 09:41 am
Servier
Tibsovo
MDS
FDA
FDA approves breast reconstruction trial using human ADM
Clinical Trials Arena
Tue, 10/24/23 - 07:45 pm
Medtech
breast reconstruction
MTF Biologics
FDA
IDE
FlexHD Pliable
human acellular dermal matrix
AZ seeks FDA okay for first self-administered flu vaccine
Pharmaphorum
Tue, 10/24/23 - 10:03 am
AstraZeneca
FDA
FluMist Quadrivalent
vaccines
flu vaccines
self-administered vaccines
BrainStorm lays off 30% of staff, slimming down for yet another bid to get ALS cell therapy to market
Fierce Biotech
Tue, 10/24/23 - 09:53 am
BrainStorm Cell Therapeutics
layoffs
FDA
ALS
NurOwn
Biora submits updated IND application for ulcerative colitis drug/device trial
Clinical Trials Arena
Tue, 10/24/23 - 09:37 am
Biora Therapeutics
ulcerative colitis
BT-600
FDA
drug-device combos
Insulet Omnipod 5 iPhone App FDA Cleared
Medical Devices and Diagnostics Industry
Mon, 10/23/23 - 05:09 pm
Medtech
Insulet
Omnipod 5
FDA
insulin delivery
diabetes
Verve gets FDA green light to run base editing study in US
BioPharma Dive
Mon, 10/23/23 - 05:01 pm
Verve Therapeutics
FDA
gene editing
heart disease
clinical trials
Intellia Gets FDA Clearance to Start First Ever Phase III Trial for an In Vivo CRISPR Drug
Xtalks
Mon, 10/23/23 - 10:31 am
Intellia Therapeutics
FDA
NTLA-2001
ATTR with cardiomyopathy
BioMarin's dwarfism therapy gets FDA nod for expanded use
Reuters
Mon, 10/23/23 - 09:08 am
BioMarin Pharmaceutical
short-limbed dwarfism
FDA
Voxzogo
Pfizer beats out GSK with FDA nod for first 5-in-1 meningitis shot
Fierce Pharma
Sun, 10/22/23 - 06:16 pm
Pfizer
GSK
vaccines
FDA
Penbraya
meningococcal disease
UCB Wins FDA Approval for Plaque Psoriasis Therapy After Regulatory Setbacks
BioSpace
Thu, 10/19/23 - 10:15 am
UCB
bimekizumab
psoriasis
FDA
Bimzelx
SeaStar Medical Nabs Breakthrough Device Designation for Hepatorenal Syndrome
Medical Devices and Diagnostics Industry
Wed, 10/18/23 - 07:47 pm
Medtech
SeaStar Medical Holdings
FDA
hepatorenal syndrome
selective cytopheretic device
BrainStorm eyes FDA meeting to find path for rejected ALS drug after withdrawing application
Fierce Biotech
Wed, 10/18/23 - 11:20 am
BrainStorm Cell Therapeutics
ALS
FDA
NurOwn
FDA approves Ardelyx's kidney disease-related drug
Reuters
Tue, 10/17/23 - 09:59 pm
Ardelyx
chronic kidney disease
FDA
Xphozah
FDA Warning Letter to J&J's Abiomed Has Broad Implications for Medtech
Medical Devices and Diagnostics Industry
Tue, 10/17/23 - 10:20 am
Medtech
JNJ
FDA
warning letters
Aldeyra Anticipates FDA Rejection of Dry Eye Drug Following Regulatory Meeting
BioSpace
Tue, 10/17/23 - 10:17 am
Aldeyra Therapeutics
dry eye disease
reproxalap
FDA
Masimo wins de novo authorization for measure of high blood oxygen levels
Medtech Dive
Mon, 10/16/23 - 11:32 pm
Masimo
Medtech
pulse oximetry
FDA
ORi

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