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Rule on Biologic Use of Master Files

[ Price : $8.95]

Federal Register notice: FDA issues a final rule to amend its regulations to address the use of master files by applications licen...

Priority Review for Lykos NDA for PTSD

[ Price : $8.95]

FDA accepts for priority review a Lykos Therapeutics NDA for midomafetamine capsules used in combination with psychological interv...

Draft Guide on Advanced Manufacturing Technologies

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FDA makes available a draft guidance entitled FDA Advanced Manufacturing Technologies Designation Program.

Workshop on Generic Drug Science

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Federal Register notice: FDA announces a 5/20-21 public workshop entitled FY 2024 Generic Drug Science and Research Initiatives Wo...

FDA Panel to Discuss Abbotts TriClip Data

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FDA convenes a 2/13 advisory committee meeting to discuss the clinical significance of Abbott Medicals TRILUMINATE pivotal trial t...

Proscia Digital Pathology Software Cleared

[ Price : $8.95]

FDA clears a Proscia 510(k) for its Concentriq AP-Dx, a diagnostic software for pathologists for viewing, interpreting, and managi...

FDA Lifts Hold on Hemogenyx CAR-T Therapy

[ Price : $8.95]

FDA removes a clinical hold against Hemogenyx Pharmaceuticals IND for the companys chimeric antigen receptor T-cells therapy for t...

Takedas Eohilia OKd for Eosinophilic Esophagitis

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FDA approves a Takeda NDA for Eohilia (budesonide oral suspension), indicated for treating eosinophilic esophagitis.

Orphan Status for Polycythemia Vera Drug

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FDA grants Disc Medicine an orphan drug designation for DISC-3405 for treating patients with polycythemia vera.

Samsung Wins De Novo for Sleep Apnea Watch, Phone

[ Price : $8.95]

FDA grants Samsung Electronics a de novo authorization for a sleep apnea feature using a compatible Samsung Galaxy Watch and phone...