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FDA Accepts Vanda BLA for Rare Skin Disorder Drug

[ Price : $8.95]

FDA accepts for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis.

Novo Nordisk Triple G Weight Loss Drug Shows Promise

[ Price : $8.95]

Novo Nordisk reports favorable weight-loss data with its triple agonist UBT251 in a Phase 2 trial in China.

Immedica Gains Accelerated OK for Arginase 1 Deficiency Therapy

[ Price : $8.95]

FDA grants Immedica Pharma an accelerated approval for its BLA for Loargys (pegzilarginase-nbln), the first therapy specifically d...

Beta Bionics Gets Warning on iLet Bionic Pancreas

[ Price : $8.95]

FDA issues Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related vi...

BioMarin Withdrawing Hemophilia A Gene Therapy

[ Price : $8.95]

BioMarin decides to voluntarily withdraw from the market its Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating...

AdvaMed Presses FDA to Anchor Federal Strategy on Clinical AI

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AdvaMed urges federal health officials to keep FDA at the center of oversight for artificial intelligence tools used in patient ca...

A.Nelson Warned on GMPs After Inspection

[ Price : $8.95]

FDA issues a Warning Letter to A. Nelson & Co. Ltd., citing significant current good manufacturing practice violations and raising...

J&J Files sBLA for Imaavy in Rare Anemia

[ Price : $8.95]

Johnson & Johnson files a supplemental BLA seeking approval of Imaavy as a treatment for warm autoimmune hemolytic anemia.

Array Wins Full Approval for Colorectal Cancer Therapy

[ Price : $8.95]

FDA grants Array BioPharma a traditional approval for its previously accelerated-approved Braftovi (encorafenib) for use in combin...

FDA Unveils Plausible Mechanism Framework Guidance

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FDA issues a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized The...