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FDA
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
FDA approves NeuroBo’s DA-1726 application to begin Phase I trial
Clinical Trials Arena
Fri, 02/2/24 - 11:55 am
NeuroBo Pharmaceuticals
DA-1726
FDA
clinical trials
obesity
Edwards receives FDA approval for first transcatheter tricuspid valve replacement treatment
Medtech Dive
Fri, 02/2/24 - 11:51 am
Medtech
Edwards Lifesciences
FDA
tricuspid trascatheter valve
Evoque
FDA commissioner Robert Califf: Adcomm reforms coming, praises AI potential
Medical Marketing and Media
Thu, 02/1/24 - 11:23 am
FDA
Robert Califf
artificial intelligence
drug shortages
Gilead’s Kite Gets FDA Approval for Faster CAR T Therapy Manufacturing
BioSpace
Wed, 01/31/24 - 11:58 am
Gilead Sciences
Kite Pharma
FDA
drug manufacturing
Yescarta
CAR-T
FDA approval numbers soar after COVID troubles
Pharmaphorum
Wed, 01/31/24 - 11:51 am
FDA
drug approvals
pandemic
COVID-19
FDA approves Farapulse pulsed field ablation tech from Boston Scientific
Mass Device
Wed, 01/31/24 - 11:48 am
Medtech
Boston Scientific
FDA
Farapulse
pulsed field ablation
FDA Clears Ascidian for First-Ever RNA Editing Trial in US
BioSpace
Tue, 01/30/24 - 09:22 pm
Ascidian Therapeutics
FDA
clinical trials
Stargardt disease
RNA editing
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