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Aldeyra Plans for Reproxalap NDA Resubmission

[ Price : $8.95]

Aldeyra Therapeutics says it will conduct a dry eye chamber clinical trial of its reproxalap in hopes of resubmitting an NDA for t...

3-year-old Fusion IV FDA-483 Released

[ Price : $8.95]

FDA releases the form FDA-483 that was issued following a 2019 inspection at the Fusion IV outsourcing facility in Los Angeles, CA...

ASCA Pilot Met, Exceeded Expectations: CDRH

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The CDRH Accreditation Scheme for Conformity Assessment pilot final report says the effort met and sometimes exceeded agency expec...

Amneal Recalls 4 Lots of Vancomycin

[ Price : $8.95]

FDA says Amneal is recalling four lots of vancomycin HCl for oral solution because some of the bottles were over-filled during the...

Eugia Recalls Methocarbamol Injection Lot

[ Price : $8.95]

Eugia U.S. recalls one lot of methocarbamol injection due to a customer product complaint about the presence of white particles fl...

FDA OKs Expanded Use for Hepatitis B Drug

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FDA approves a Gilead Sciences supplemental NDA for Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for ch...

Synaptive Medical Fluorescence Module Cleared

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FDA clears a Synaptive Medical 510(k) for its near-infrared fluorescence visualization module, Modus IR, adding to the existing fl...

Medexus Hemophilia B Factor Gets Expanded Use

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FDA approves a Medexus Pharmaceuticals supplemental BLA for Ixinity [coagulation factor IX (recombinant)] for treating pediatric p...

FDA Withdraws 30 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of 30 abbreviated new drug applications from multiple applicants because the drug ...

OTC Monograph Drug User Fees

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Federal Register notice: FDA announces the over-the-counter Monograph Drug User Fee Program facility fee rates for fiscal year 202...