FDA

Former FDA official says agency dysfunction led to baby formula crisis
Boston Globe
Wed, 03/29/23 - 10:03 am
FDA
infant formula
shortages
FDA lifts partial hold on Blueprint's CDK2 inhibitor
Endpoints
Wed, 03/29/23 - 09:43 am
Blueprint Medicines
cancer
CDK2 inhibitor
FDA
FDA committee will hear Perrigo's OTC bid for birth control med Opill in May
Fierce Pharma
Tue, 03/28/23 - 10:50 pm
FDA
Perrigo
contraceptives
Opill
FDA details plan to end emergency use authorizations for devices
Medtech Dive
Mon, 03/27/23 - 10:01 pm
devices
Medtech
FDA
COVID-19
Emergency Use Authorization
Proposed FDA guidelines to strengthen oversight on accelerated approval cancer drugs
Medical Marketing and Media
Mon, 03/27/23 - 09:57 pm
FDA
clinical trials
cancer
oncology
accelerated approvals
FDA floats oncology authorization shake-up, pitching 'one-trial' model for accelerated and full approval
Fierce Biotech
Mon, 03/27/23 - 10:14 am
FDA
oncology
regulatory
BrainStorm Secures FDA Adcomm for ALS Therapy NurOwn
BioSpace
Mon, 03/27/23 - 10:08 am
BrainStorm Cell Therapeutics
NurOwn
ALS
FDA
FDA approves Pharming drug for ultra-rare immunodeficiency disease
Endpoints
Sun, 03/26/23 - 11:16 pm
FDA
Pharming
Novartis
leniolisib
APDS
FDA outlines plan for digital health technologies for clinical trials
RAPS.org
Sun, 03/26/23 - 11:15 pm
FDA
regulatory
clinical trials
digital health
Brii Bio shelves once-promising COVID antibody combo that stood up to variants
Fierce Pharma
Fri, 03/24/23 - 11:40 am
Brii Biosciences
COVID-19
BRII-196/198
China
FDA
Incyte hit by CRL on extended-release JAK tablets, muddying plans for Jakafi franchise expansion
Endpoints
Fri, 03/24/23 - 10:05 am
Incyte
FDA
ruxolitinib
CRL
Future of abortion pills hangs in the balance as court hears case against mifepristone
Medical Marketing and Media
Fri, 03/24/23 - 10:00 am
abortion pills
FDA
mifepristone
Secura Bio to keep offering blood cancer drug despite negative ODAC vote, OS questions
Endpoints
Thu, 03/23/23 - 08:59 pm
Secura Bio
Copiktra
CLL
small lymphocytic lymphoma
FDA
FDA approves new antifungal as concerns grow over drug-resistant fungus
BioPharma Dive
Thu, 03/23/23 - 08:53 pm
FDA
Cidara Therapeutics
Melinta Therapeutics
antifungals
candidemia
candidiasis
Rezzayo
Ionis Rockets As Biogen-Partnered ALS Drug Wins Key Endorsement
Investors Business Daily
Thu, 03/23/23 - 09:58 am
Ionis Pharmaceuticals
Biogen
ALS
FDA
tofersen
In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type
Fierce Pharma
Wed, 03/22/23 - 09:27 pm
Incyte
Zynyz
FDA
Merkel cell carcinoma
FDA advisers support conditional clearance of Biogen’s ALS drug
BioPharma Dive
Wed, 03/22/23 - 09:23 pm
Biogen
ALS
FDA
tofersen
FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up
Fierce Pharma
Wed, 03/22/23 - 11:14 am
Regeneron
Evkeeza
pediatric
Homozygous Familial Hypercholesterolemia
FDA
FDA to soon decide on second round of Omicron-tailored boosters
Reuters
Tue, 03/21/23 - 10:00 pm
COVID-19
vaccines
boosters
Omicron
FDA
Despite CMS snub, Eisai is 'not so nervous' about Leqembi's long-term coverage prospects: US CEO
Fierce Pharma
Tue, 03/21/23 - 09:58 pm
Eisai
Leqembi
FDA
CMS
Alzheimer's disease

Pages