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FDA Rejects Lipocine NDA for Testosterone Drug

[ Price : $8.95]

FDA issues Lipocine a complete response letter on its NDA for Tlando, an oral testosterone product candidate for testosterone repl...

OTC Labeling Info Collection Extension

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Federal Register notice: FDA submits to OMB an information collection extension for Format and Content Requirements for Over-the-C...

Small Pharmacyֺs Role in Ranitidine Concerns

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Start-up pharmacy Valisure makes a name for itself by chemically validating drugs it purchases from wholesalers before fulfilling ...

Firm Sues FDA to Reverse Clinical Hold

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Regenxbio files a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases.

Breakthrough for AI System for Endoscopy Images

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FDA grants AI Medical Service a Breakthrough Device Designation for its artificial intelligence programs that analyze endoscopy im...

Allergan Drug Gains Infectious Disease Designation

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FDA grants Allergan a Qualified Infectious Disease Product designation and fast track status for ATM-AVI (aztreonam and avibactam)...

Aurobindo Recalls Ranitidine Products

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FDA says Aurobindo has recalled 38 lots of ranitidine products for unacceptable NDMA levels.

FDA Approves Celgenes Reblozyl for Some Anemic Adults

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FDA approves Celgenes Reblozyl as the first treatment for adults with anemia who have beta thalassemia and require regular red blo...

Cassiopea NDA Filed for New Acne Cream

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FDA accepts for review a Cassiopea NDA for clascoterone cream 1% for treating acne.

E-cigarette Rule Coming: Trump

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President Trump says new e-cigarette rules will be out within a week, including raising the purchasing age from 18 to 21.