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Sarepta Duchenne BLA Heads to Panel

[ Price : $8.95]

Federal Register notice: FDA announces a 5/12 Advisory Committee meeting to review a Sarepta Therapeutics BLA for a Duchenne muscu...

Reach Neuro Wins Breakthrough for Stroke Stimulator

[ Price : $8.95]

FDA grants Reach Neuro a breakthrough designation for its Avantis platform, which the company says uses small electrical impulses ...

DoJ Formally Appeals Mifepristone Texas Order

[ Price : $8.95]

The Department of Justice officially appeals Texas federal judge Matthew J. Kacsmaryks 4/7 controversial court order to undo FDAs ...

Merck, Eisai Discontinue Melanoma Trial

[ Price : $8.95]

Merck and Eisai say they are discontinuing the Phase 3 LEAP-003 trial evaluating Keytruda plus Lenvima for first-line treatment of...

Horizon Therapeutics Touts Thyroid Eye Disease Data

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Horizon Therapeutics says it plans to discuss with FDA positive and statistically significant topline results from a Phase 4 clini...

Sumitomo Pharma Gets Orphan Designation

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FDA grants Sumitomo Pharma Oncology an Orphan Drug Designation for TP-1287, an investigational oral CDK9 inhibitor for treating Ew...

Phillips Recalls DreamStation Breathing Devices

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Philips recalls (Class1) certain reworked DreamStation breathing devices due to some devices being assigned incorrect or duplicate...

e-Import Entries Information Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Imports and Electronic Import Entries ...

Quinacrine HCl Added to Bulk Compounding List

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Federal Register notice: FDA adds quinacrine hydrochloride to its list of bulk drug substances (active pharmaceutical ingredients ...

Two Imbruvica Accelerated Approvals Withdrawn

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Janssen Biotech and Pharmacyclics decide to voluntarily withdraw two accelerated approval indications for Imbruvica (ibrutinib) t...