FDA

UCB takes on Jazz in severe epilepsy with new Fintepla approval
Pharmaforum
Mon, 03/28/22 - 10:06 am
UCB Pharma
FDA
Fintepla
Lennox-Gastaut Syndrome
Jazz Pharma
Epidiolex
Officials limit an antibody therapy, saying it’s ineffective against BA.2 variant of Omicron
Stat
Sun, 03/27/22 - 04:00 pm
Vir Biotechnology
GSK
monoclonal antibodies
sotrovimab
COVID-19
Omicron BA.2
FDA
Stakeholders ask for more time to transition EUA devices, diagnostics
RAPS.org
Tue, 03/29/22 - 01:36 pm
FDA
regulatory
Emergency Use Authorizations
devices
diagnostics
Medtech
How Covid failed to derail the FDA
EP Vantage
Sun, 03/27/22 - 03:48 pm
COVID-19
FDA
regulatory
FDA Concerns Over PI3K Inhibitors Snag MEI Pharma, Kyowa Kirin
BioSpace
Fri, 03/25/22 - 10:35 am
MEI Pharma
Kyowa Kirin
FDA
zandelisib
PI3k inhibitor
Bristol Myers Squibb, Merck hit setback in bid to expand Reblozyl's anemia nod
Fierce Pharma
Fri, 03/25/22 - 10:33 am
Bristol Myers Squibb
Merck
Reblozyl
FDA
beta thalassemia
Google seeks FDA nod for passive AFib detection with Fitbit
Pharmaforum
Fri, 03/25/22 - 10:27 am
Google
FDA
Fitbit
atrial fibrillation
Medtech
devices
FDA urges COVID-19 test makers with EUAs to seek full authorizations
Medtech Dive
Fri, 03/25/22 - 10:25 am
diagnostics
FDA
COVID-19
Emergency Use Authorization
With competitors circling, ViiV wins another label update for long-acting HIV injectable Cabenuva
Endpoints
Thu, 03/24/22 - 08:33 pm
ViiV Healthcare
GSK
FDA
Cabenuva
HIV
Janssen
Moderna wants to give FDA ‘flexibility’ in deciding eligibility for 4th Covid shot, CEO says
CNBC
Thu, 03/24/22 - 08:30 pm
Moderna Therapeutics
vaccines
boosters
COVID-19
FDA
In Expected Decision, FDA Rejects Lilly's Sintilimab in NSCLC
BioSpace
Thu, 03/24/22 - 10:58 am
Eli Lilly
sintilimab
FDA
NSCLC
The year the regulators meet the microbiome
EP Vantage
Thu, 03/24/22 - 10:47 am
microbiome
Seres Therapeutics
Ferring Pharmaceuticals
FDA
C. difficile
Moderna to ask FDA to authorize Covid-19 vaccine in children 6 months to 6 years
Stat
Wed, 03/23/22 - 10:42 am
Moderna Therapeutics
FDA
vaccines
COVID-19
pediatric
Return of Takeda’s Parathyroid Hormone Injection Delayed Indefinitely
BioSpace
Tue, 03/22/22 - 11:16 pm
Takeda
parathyroid
hypoparathyroidism
Natpara
FDA
FDA Clears the Way for NeuroSense's PrimeC Candidate for ALS
BioSpace
Tue, 03/22/22 - 10:46 am
NeuroSense Therapeutics
PrimeC
ALS
FDA
FDA approves Merck’s anti-PD-1 therapy for endometrial carcinoma patients
Pharmaceutical Business Review
Tue, 03/22/22 - 10:41 am
Merck
Keytruda
endometrial cancer
FDA
FDA seeks to streamline inactive ingredient database with industry input
RAPS.org
Mon, 03/21/22 - 10:34 pm
FDA
regulatory
inactive ingredients
U.S. FDA advisers to discuss COVID vaccine boosters in April
Yahoo/Reuters
Mon, 03/21/22 - 10:50 am
FDA
COVID-19
vaccines
boosters
First Therapy Approved for Marinus and Seizures Associated with CDD
BioSpace
Mon, 03/21/22 - 10:43 am
Marinus Pharmaceutical
FDA
CDD
seizures
Ztalmy
FDA sets August decision date for Provention’s type 1 diabetes drug
Pharmaforum
Mon, 03/21/22 - 10:15 am
Provention Bio
type 1 diabetes
FDA
teplizumab

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