FDA

FDA shares additional draft guidance on cell and gene therapy
Clinical Trials Arena
Wed, 11/20/24 - 11:20 am
FDA
regulatory
gene therapy
cell therapy
Astellas CRL ‘clearly a positive’ for Apellis, says JPMorgan
Tip Ranks
Tue, 11/19/24 - 11:13 am
Astellas
Apellis
FDA
geographic atrophy
Izervay
Syfovre
FDA endorses speedy approval path for Regenxbio Duchenne gene therapy
BioPharma Dive
Mon, 11/18/24 - 06:32 pm
Rengexbio
DMD
gene therapy
FDA
RGX-202
Trump’s Second Term Could Turn LDT Regulation on its Head
Medical Devices and Diagnostics Industry
Sun, 11/17/24 - 09:32 pm
LDTs
Medtech
devices
FDA
Donald Trump
FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
Benzinga
Fri, 11/15/24 - 11:15 am
Regeneron
Sanofi
Dupixent
FDA
chronic spontaneous urticaria
FDA approves Danziten, the first nilotinib treatment for Ph+ CML with no mealtime restrictions
CP Wire
Thu, 11/14/24 - 10:25 pm
Azurity
Danziten
Ph+ CML
FDA
Novartis
Tasigna
FDA approves Danziten, the first nilotinib treatment for Ph+ CML with no mealtime restrictions
Thu, 11/14/24 - 07:28 pm
Azurity
Danziten
Ph+ CML
FDA
Novartis
Tasigna
Intelligent gears up for FDA approval of fingerprint drug detection device
Clinical Trials Arena
Thu, 11/14/24 - 11:16 am
Intelligent Bio Solutions
FDA
Medtech
fingerprint drug screening
PTC's brain-delivered gene therapy gets US nod for rare genetic disorder
First Word Pharma
Thu, 11/14/24 - 09:59 am
PTC Therapeutics
FDA
Kebilidi
AADC deficiency
[podcast]FDA's Foreign Inspections of Drug Manufacturers Have Not Rebounded to Pre-Pandemic Levels
GAO,gov
Wed, 11/13/24 - 09:44 pm
GAO
regulatory
foreign drug inspections
FDA
After election, FDA's Califf lays out hopes for his Trump-appointed successor
Fierce Pharma
Wed, 11/13/24 - 11:22 am
FDA
Robert Califf
regulatory
FDA hits Kezar's zetomipzomib program with 2nd clinical hold in 2 months
Fierce Biotech
Wed, 11/13/24 - 11:09 am
Kezar Life Sciences
FDA
zetomipzomib
clinical trials
autoimmune hepatitis
AstraZeneca, Daiichi withdraw lung cancer approval application for Enhertu follow-up and try again
Fierce Biotech
Tue, 11/12/24 - 08:44 pm
AstraZeneca
Daiichi Sankyo
lung cancer
FDA
Dato-DXd
Enhertu
FDA declines full approval for Intercept's liver disease drug
Pharma Live
Tue, 11/12/24 - 11:10 am
Intercept Pharma
Ocaliva
FDA
primary biliary cholangitis
liver disease
Autolus enters CAR-T race with FDA approval for Aucatzyl
Fierce Pharma
Mon, 11/11/24 - 11:49 am
Autolus Therapeutics
CAR-T
FDA
Aucatzyl
Gilead Sciences
Novartis
relapsed or refractory B-cell precursor acute lymphoblastic leukemia
FDA Lifts Clinical Hold on Novavax’s COVID/Flu Vaccine Candidates, Clears Phase III Trial
BioSpace
Mon, 11/11/24 - 11:42 am
Novavax
COVID/flu vaccine
vaccines
FDA
clinical trials
Zeta Surgical nabs expanded FDA clearance ahead of brain surgery navigation system rollout
Fierce Biotech
Mon, 11/11/24 - 11:34 am
Medtech
Zeta Surgical
brain surgery
FDA
J&J angles Darzalex for first move into early-stage myeloma with trial win, FDA filing
Fierce Pharma
Fri, 11/8/24 - 11:52 am
JNJ
Darzalex
Multiple Myeloma
FDA
What RFK Jr.’s influence could mean for pharma
Pharma Voice
Fri, 11/8/24 - 11:45 am
Robert F Kennedy Jr.
Donald Trump
healthcare reform
FDA
CDC
CMS
NIH
J&J Joins Medtronic & Boston Sci in PFA Race with FDA Approval of Varipulse
Medical Devices and Diagnostics Industry
Fri, 11/8/24 - 12:03 am
Medtech
JNJ
Varipulse
FDA
atrial fibrillation
Medtronic
Boston Scientific

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