FDA

GSK's oral anemia drug Jesduvroq scores partial FDA nod after 2 rivals suffered rejections
Fierce Pharma
Thu, 02/2/23 - 10:28 am
GSK
FDA
daprodustat
Jesduvroq
anemia
chronic kidney disease
GSK receives orphan drug designation for Benlysta to treat systemic sclerosis
Pharmaceutical Business Review
Thu, 02/2/23 - 10:25 am
GSK
FDA
orphan drugs
Benlysta
systemic sclerosis
A renewed push into early bladder cancer
EP Vantage
Thu, 02/2/23 - 10:24 am
Ferring Pharmaceuticals
Adstiladrin
FDA
gene therapy
bladder cancer
FDA axes requirement for positive Covid test before Paxlovid use
Endpoints
Wed, 02/1/23 - 10:24 pm
FDA
Paxlovid
COVID-19
Taysha’s GAN Gene Therapy Hits FDA Speedbump
BioSpace
Wed, 02/1/23 - 10:35 am
Taysha Gene Therapies
TSHA-120
axonal neuropathy
clinical trials
gene therapy
FDA
Legislative Hurdles Anticipated for Biopharma in 2023
BioSpace
Wed, 02/1/23 - 10:34 am
legislation
M&A
FDA
Inflation Reduction Act
First Wave BioPharma to initiate trial of adrulipase for cystic fibrosis
Clinical Trials Arena
Wed, 02/1/23 - 10:27 am
First Wave Biopharma
clinical trials
cystic fibrosis
FDA
adrulipase
FDA restores orphan-exclusivity system after 18-month stall in wake of legal feud
Medical Marketing and Media
Tue, 01/31/23 - 11:25 pm
FDA
orphan drugs
exclusivity
In mysterious FDA approval, Pfizer quietly wins Ibrance breast cancer expansion
Fierce Pharma
Tue, 01/31/23 - 11:11 pm
Pfizer
Ibrance
FDA
breast cancer
Amid application tsunami, FDA's top cell and gene therapy leader to retire in March
Endpoints
Tue, 01/31/23 - 11:09 pm
FDA
gene therapy
cell therapy
FDA to resume in-person formal meetings in February
RAPS.org
Mon, 01/30/23 - 05:54 pm
FDA
regulatory
pandemic
COVID-19
Moderna Granted FDA Breakthrough Therapy Designation for mRNA-1345, An Investigational Respiratory Syncytial Virus (RSV) Vaccine Candidate
BioSpace
Mon, 01/30/23 - 10:37 am
Moderna Therapeutics
FDA
mRNA-1345
vaccines
RSV
breakthrough therapy
Lilly enters ripe BTK field with quick FDA nod in mantle cell lymphoma
Endpoints
Sun, 01/29/23 - 02:14 pm
Eli Lilly
Btk inhibitors
FDA
Merck
mantle cell lymphoma
Jaypirca
Following FDA COVID vaccine advisory panel vote, Novavax is prepared to provide a revised vaccine
CP WIre
Sun, 01/29/23 - 02:11 pm
Novavax
FDA
vaccines
COVID-19
boosters
Following FDA COVID vaccine advisory panel vote, Novavax is prepared to provide a revised vaccine
Sun, 01/29/23 - 02:10 pm
Novavax
FDA
vaccines
COVID-19
boosters
FDA advisers back agency plan to simplify COVID-19 vaccination
BioPharma Dive
Thu, 01/26/23 - 11:51 pm
FDA
COVID-19
vaccines
FDA yanks EUA for AstraZeneca’s Evusheld as COVID variants continue to evolve
Medical Marketing and Media
Thu, 01/26/23 - 05:07 pm
AstraZenenca
FDA
Evusheld
COVID-19
Emergency Use Authorization
FDA accepts Intercept’s resubmitted NDA for obeticholic acid
Clinical Trials Arena
Thu, 01/26/23 - 10:51 am
FDA
Intercept Pharma
OCA
obeticholic acid
NASH
Sanofi dives deeper into phase 3 data for Hemlibra rival as FDA decision approaches
Fierce Biotech
Thu, 01/26/23 - 10:47 am
Sanofi
FDA
clinical trials
hemophilia A
efanesoctocog alfa
Roche
Hemlibra
FDA advisers back Cidara and Melinta’s antifungal treatment
BioPharma Dive
Thu, 01/26/23 - 10:42 am
FDA
Cidara Therapeutics
Melinta Therapeutics
antifungals
candidemia
candidiasis
rezafungin

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