FDA

AstraZeneca, Daiichi aim for first pan-tumor ADC approval
BioPharma Dive
Mon, 01/29/24 - 11:25 am
AstraZeneca
Daiichi Sankyo
antibody-drug conjugate
Enhertu
pan-tumor
FDA
FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain
Medtech Dive
Mon, 01/29/24 - 10:55 am
FDA
devices
Medtech
digital health
cybersecurity
Amgen’s Prolia Gets FDA Boxed Warning for Risk of Severe Hypocalcemia
Xtalks
Sun, 01/28/24 - 06:28 pm
Amgen
Prolia
hypocalcemia
FDA
warnings
osteoporosis
Sanofi, Regeneron Win Dupixent Label Expansion to Treat Eosinophilic Esophagitis
BioSpace
Fri, 01/26/24 - 11:19 am
Regeneron
Sanofi
Dupixent
eosinic esophagitis
pediatric
FDA
FDA Misses PDUFA Date for Liquidia’s NDA for Inhaled Blood Pressure Drug
BioSpace
Thu, 01/25/24 - 09:01 pm
Liquidia
FDA
Yutrepia
hypertension
UroGen submits new drug application to FDA for UGN-102
Pharmaceutical Business Review
Thu, 01/25/24 - 11:31 am
Urogen
FDA
UGN-102
urothelial cancer
FDA Reveals More Details on 22 CAR-T Secondary Cancer Cases
BioSpace
Thu, 01/25/24 - 11:03 am
CAR-T
cancer
FDA
Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings
Fierce Pharma
Wed, 01/24/24 - 10:46 am
Gilead Sciences
Tecartus
CAR-T
FDA
J&J, Legend to Face Adcomm for Carvykti’s Push as Earlier Line MM Treatment
BioSpace
Wed, 01/24/24 - 10:40 am
JNJ
Legend Biotech
FDA
Carvykti
Multiple Myeloma
Inside the FDA’s plans for the largest reorganization in its history
Medical Marketing and Media
Tue, 01/23/24 - 10:55 am
FDA
regulatory
reorganization
FDA requires 'boxed warning' for CAR-T cancer therapies
Reuters
Mon, 01/22/24 - 10:10 pm
CAR-T
FDA
warnings
Gilead Sciences
JNJ
Novartis
FDA’s Marks Advocates for Flexibility in Rare Disease Gene Therapy Trials
BioSpace
Mon, 01/22/24 - 11:01 am
FDA
regulatory
Peter Marks
CBER
clinical trials
gene therapy
FDA adds 'boxed warning' for Amgen's Prolia
Reuters
Fri, 01/19/24 - 11:26 am
Amgen
Prolia
FDA
warnings
NeuroSigma gets green light from FDA for ADHD wearable
Clinical Trials Arena
Thu, 01/18/24 - 11:09 am
NeuroSigma
FDA
ADHD
Monarch eTNS
wearables
Medtech
FDA declines to approve Shin Nippon Biomedical's migraine drug
Reuters
Thu, 01/18/24 - 11:05 am
FDA
Shin Nippon Biomedical
migraines
Congressional watchdog will launch inquiry into FDA oversight of medical device recalls
Medical Marketing and Media
Wed, 01/17/24 - 08:38 pm
GAO
FDA
regulatory
Medtech
device recalls
Takeda Gets FDA Label Expansion for HyQvia in Rare Autoimmune Disorder
BioSpace
Wed, 01/17/24 - 08:27 pm
Takeda
FDA
HyQvia
demyelinating polyneuropathy
BrainSee AI-Powered Dementia Test Receives FDA Approval
Xtalks
Wed, 01/17/24 - 08:23 pm
Medtech
Darmiyan
FDA
diagnostics
BrainSee
demential
artificial intelligence
FDA widens approval of Vertex’s CRISPR medicine to treat beta thalassemia
BioPharma Dive
Wed, 01/17/24 - 09:34 am
Vertex Pharmaceuticals
CRISPR Therapeutics
Casgevy
beta thalassemia
FDA
FDA updates Sanofi’s Dupixent label for atopic dermatitis
Pharmaceutical Business Review
Wed, 01/17/24 - 09:26 am
Sanofi
Dupixent
FDA
atopic dermatitis

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