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FDA
FDA fast tracks Diamyd’s immunotherapy for managing type 1 diabetes
Clinical Trials Arena
Thu, 02/15/24 - 07:15 pm
Diamyd
FDA
fast track
type 1 diabetes
Masimo wins first FDA clearance for OTC medical fingertip pulse oximeter
Medtech Dive
Wed, 02/14/24 - 06:34 pm
Masimo
OTC
FDA
Medtech
pulse oximeter
Rocket Pharma gets FDA review extension review of gene therapy
Investing.com
Tue, 02/13/24 - 11:19 pm
Rocket Pharmaceuticals
gene therapy
FDA
Kresladi
Abbott's heart valve repair device gets FDA advisers' backing
Reuters
Tue, 02/13/24 - 11:14 pm
Abbott Labs
Medtech
FDA
TriClip
tricuspid valve regurgitation
With FDA nod for Onivyde combo, Ipsen ends 10-year drought in newly diagnosed pancreatic cancer
Fierce Pharma
Tue, 02/13/24 - 11:12 pm
Ipsen
Onivyde
Nalirifox
pancreatic cancer
FDA
FDA grants orphan drug designation for Disc’s PV treatment
Pharmaceutical Business Review
Mon, 02/12/24 - 11:45 am
Disc Medicine
DISC-3405
polycythemia vera
FDA
FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen
Pharmaphorum
Mon, 02/12/24 - 10:28 am
GSK
FDA
fast track
hepatitis B
bepirovirsen
antisense
FDA approves Takeda's therapy for allergic inflammation in esophagus
Reuters
Mon, 02/12/24 - 10:21 am
Takeda
FDA
Eohilia
eosinophilic esophagitis
FDA repeatedly rejected safety claims made by Philips after the CPAP recall but waited to alert the public, emails show
Medical Marketing and Media
Sun, 02/11/24 - 03:48 pm
Philips
Medtech
FDA
regulatory
recalls
CPAP
FDA staff raises no new concerns about Abbott's heart device
Reuters
Sun, 02/11/24 - 03:45 pm
FDA
Abbott Labs
Medtech
TriClip
tricuspid valve regurgitation
Veru needs additional cash for fresh trial of respiratory distress drug
Fierce Biotech
Thu, 02/8/24 - 11:09 am
Veru
respiratory distress
RSV
COVID-19
FDA
Drug Shortages Aren’t Over. And There’s Little Progress Toward Ending Them
BioSpace
Wed, 02/7/24 - 09:24 pm
FDA
GAO
drug shortages
FDA puts hold on Gilead's blood cancer therapy trials
Reuters
Wed, 02/7/24 - 09:20 pm
Gilead Sciences
FDA
clinical trials
magrolimab
blood cancer
Eisai, Biogen likely to miss early launch goal for Alzheimer's drug Leqembi
Fierce Pharma
Wed, 02/7/24 - 11:33 am
Eisai
Biogen
FDA
Medicare
Leqembi
Alzheimer's disease
FDA finds control lapses at Catalent plant being sold to Novo
Reuters
Tue, 02/6/24 - 11:36 pm
FDA
drug manufacturing
regulatory
Novo Nordisk
Catalent
FDA Clears First Non-drug Prescription Device for Women with Osteopenia
Medical Devices and Diagnostics Industry
Tue, 02/6/24 - 11:25 pm
Medtech
FDA
osteopenia
OsteoBoost
Bone Health Technologies
FDA awarded record number of review designations to CRISPR drugs in 2023
Biopharma Reporter
Tue, 02/6/24 - 09:16 am
CRISPR
FDA
gene editing
CRISPR Therapeutics
Vertex Pharmaceuticals
Valneva sells regulatory ‘fast pass’ for $103M
BioPharma Dive
Tue, 02/6/24 - 09:14 am
Valneva
FDA
fast pass
Ixchiq
FDA officials say different communication methods needed to ensure AI/ML transparency
RAPS.org
Mon, 02/5/24 - 10:52 pm
FDA
artificial intelligence
machine learning
transparency
FDA website shows limited availability of some doses of Lilly's Mounjaro
Reuters
Mon, 02/5/24 - 10:12 am
FDA
drug shortages
Eli Lilly
Mounjaro
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