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Sarepta Submits BLA for Duchenne Gene Therapy

[ Price : $8.95]

Sarepta Therapeutics files a BLA seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patient...

Dupixent Gains OK for Prurigo Nodularis

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FDA approves Regeneron Pharmaceuticals Dupixent (dupilumab) for treating adult patients with prurigo nodularis. a chronic, inflamm...

Comments on COA Guidance

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Four stakeholders suggest ways FDA could improve a draft guidance on fit-for-use clinical outcome assessments.

Generic Adspec Approved for Bovine Pneumonia

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FDA approves Bimeda Animal Healths SpectoGard (spectinomycin sulfate), the first generic copy of Pharmacia Animal Healths Adspec....

Mfr. Deficiencies Hamper 1st Cycle ANDA Reviews

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Writing in a medical journal, CDER researchers say manufacturing-related deficiencies contribute significantly to a low first-revi...

Senate OKs Bill Ending Animal Testing Mandates

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The Senate unanimously approves legislation to end an FDA mandate for animal testing of experimental drugs before they can be used...

Medtronics Hemostasis Agent Cleared for Upper GI

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FDA clears a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system.

Amylyx Lou Gehrigs Disease Drug Approved

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FDA approves Amylyxs amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate a...

Final Guide on Revised Covid Test Policy

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Federal Register notice: FDA makes available a final guidance entitled Policy for Coronavirus Disease 2019 Tests During the Publi...

OTC Monograph eSubmission Guide

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Federal Register notice: FDA makes available a draft guidance entitled Providing Over-the-Counter Monograph Submissions in Electro...