FDA

Concert persuades FDA to keep breakthrough tag for alopecia therapy despite Lilly's arrival
Fierce Biotech
Wed, 02/15/23 - 10:48 am
Concert Pharmaceuticals
alopecia areata
FDA
breakthrough therapy
deuruxolitinib
Eli Lilly
olumiant
FDA adds warning of 'larger areas of bleeding' in brain to Biogen's Aduhelm label
Endpoints
Tue, 02/14/23 - 11:01 am
Biogen
Aduhelm
FDA
Alzheimer's disease
FDA clears Pharmazz’s IND for acute cerebral ischaemic stroke therapy trial
Clinical Trials Arena
Tue, 02/14/23 - 10:48 am
Pharmazz
sovateltide
stroke
cerebral ischemia
FDA
FDA Rejects Soligenix's Lymphoma Candidate
BioSpace
Tue, 02/14/23 - 10:41 am
FDA
Soligenix
HyBryte
cutaneous T-cell lymphoma
Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints
RAPS.org
Mon, 02/13/23 - 10:07 pm
FDA
drug approvals
clinical trials
FDA rejects Biocon and Viatris' Avastin biosimilar after inspection question marks
Endpoints
Mon, 02/13/23 - 10:02 pm
FDA
Biocon
Viatris
Avastin
biosimilars
drug manufacturing
GSK's unusual Jemperli expansion plan wins FDA panel backing—with a twist
Fierce Pharma
Fri, 02/10/23 - 11:21 am
GSK
rectal cancer
Jemerpli
FDA
Galapagos' Jyseleca flops phase 3 Crohn's study, dealing another blow to troubled JAK inhibitor
Fierce Pharma
Fri, 02/10/23 - 11:09 am
Galapagos
FDA
filgotinib
Crohn's Disease
clinical trials
Jyseleca
FDA hands down a partial hold for PhI/II trial of Blueprint’s CDK2 inhibitor
Endpoints
Fri, 02/10/23 - 11:05 am
FDA
Blueprint Medicine
clinical trials
solid tumors
BLU-222
Still no green light for Phathom's gastrointestinal drugs after impurities found in batches
Endpoints
Fri, 02/10/23 - 10:30 am
Phanthom Pharmaceuticals
gastrointestinal
FDA
FDA offers former biotech unicorn Intarcia a chance for a panel review
BioPharma Dive
Thu, 02/9/23 - 06:04 pm
FDA
Intarcia
diabetes
drug-eluting
ITCA 650
Bydureon
Califf addresses inspections, staffing and COVID response in House hearing
RAPS.org
Wed, 02/8/23 - 11:02 pm
FDA
Robert Califf
COVID
regulatory inspections
Vistagen, jittery after seeing rivals fail, pauses plan to restart phase 3 anxiety trial pending FDA talks
Fierce Biotech
Wed, 02/8/23 - 10:27 am
VistaGen
FDA
clinical trials
anxiety
PH94B
FDA assembles adcomm to review GSK's Jemperli trial plans in rectal cancer
Endpoints
Tue, 02/7/23 - 06:50 pm
FDA
GSK
rectal cancer
Jemperli
Sandoz files biosimilar of Amgen osteoporosis drug in US
Pharmaphorum
Tue, 02/7/23 - 12:22 pm
Sandoz
Novartis
biosimilars
osteoporosis
Prolia
Xgeva
FDA
Aldeyra’s sights set on November PDUFA
Endpoints
Tue, 02/7/23 - 11:57 am
Aldeyra Therapeutics
dry eye disease
reproxalap
FDA
Biogen, Sage Get FDA Priority Review of Zuranolone
Marketwatch
Mon, 02/6/23 - 10:47 am
Biogen
SAGE Therapeutics
FDA
zuranolone
priority review
postpartum depression
major depressive disorder
Gilead's Trodelvy snags vital breast cancer nod
Fierce Pharma
Mon, 02/6/23 - 10:44 am
Gilead Sciences
FDA
Trodelvy
breast cancer
HR-positive HER-negative breast cancer
This Week at FDA: Restructuring at inspections office, new guidances and staff, and more
RAPS.org
Mon, 02/6/23 - 10:34 am
FDA
regulatory
regulatory inspections
Paxlovid
Jesduvroq
GSK
Pfizer
Is MaaT back? After 18 months on hold, microbiome biotech sees end to impasse with FDA
Fierce Biotech
Fri, 02/3/23 - 10:55 am
MaaT Pharma
microbiome
FDA
fecal microbiome
MaaT013

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