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Loxo Announces Breakthrough Therapy Designation from FDA for LOXO-292 americanpharmaceuticalreview
September 06, 2018
Loxo Oncology announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor
ADMA Biologics Reports FDA Compliance Status Update americanpharmaceuticalreview
September 06, 2018
ADMA Biologics announces that the U.S. Food and Drug Administration (FDA) inspection database classification website has been updated and confirms ADMA’s compliance status has improved to Voluntary Action Indicated (VAI).
Fibrocell Announces FDA Fast Track Designation of FCX-013 americanpharmaceuticalreview
September 06, 2018
Fibrocell Science announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FCX-013, the Company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma, a chronic, debilitating genet
FDA’s Review Progress of Noteworthy Pharmaceutical Products in the Second Half of the Year 1°C
September 05, 2018
Drugs Approved by FDA Expected to Exceed 50 in 2018
FDA Tentatively Approves Sympazan Oral Film americanpharmaceuticalreview
September 05, 2018
Aquestive Therapeutics announced that Sympazan (clobazam) oral film has received tentative approval by the U.S. Food and Drug Administration (FDA), for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years
Eiger Announces Positive Meeting with FDA on Progeria Program americanpharmaceuticalreview
September 05, 2018
Eiger BioPharmaceuticals has received minutes from a pre-investigational new drug (pre-IND) meeting with the Division of Gastroenterology and Inborn Errors Products of the U.S. Food and Drug Administration (FDA) for lonafarnib in the treatment of Hutchins
FDA Announces Voluntary Recall of Montelukast americanpharmaceuticalreview
September 05, 2018
The U.S. Food and Drug Administration (FDA) is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Piscataway, N.J.
FDA piloting innovative clinical trial designs europeanpharmaceuticalreview
September 05, 2018
The US FDA is looking to begin a new phase of innovative clinical trial designs…
US FDA inspects Lupin’s Tarapur API facility financialexpress
September 04, 2018
Rules out presence of NDMA impurity in co’s Valsartan, Losartan and Irbesartan APIs
Aquestive Therapeutics Announces Tentative FDA Approval for Sympazan™ (clobazam) Oral Film pharmafocusasia
September 04, 2018
Aquestive Therapeutics, Inc. today announced that Sympazan™ (clobazam) oral film has received tentative approval by the U.S. Food and Drug Administration (FDA), for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pati

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