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Imbruvica, Rituxan Combination sNDA Accepted for Review by FDA americanpharmaceuticalreview
June 27, 2018
AbbVie announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglo
WuXi STA Enables Ascletis to Receive NDA Approval from China FDA for Ganovo contractpharma
June 19, 2018
STA Pharmaceutical, a subsidiary of WuXi AppTec, said that its partner, Ascletis has received approval from China Food and Drug Administration (CFDA) for its Category 1 new drug, Ganovo, also known as Danoprevir or ASC08, to treat viral hepatitis C.
Glenmark Pharmaceuticals Announces the Company's First NDA for Ryaltris for Patients with Seasonal Allergic Rhinitis drugs
May 31, 2018
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for its leading respiratory pipeline candidate Ryaltris™ (rye - al' - tris)
AcelRx Announces FDA Acceptance of NDA for DSUVIA drugs
May 31, 2018
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings
Aerie Pharmaceuticals Submits NDA to FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% drugs
May 17, 2018
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery,
Sage Therapeutics Submits NDA for Intravenous Brexanolone americanpharmaceuticalreview
April 24, 2018
Sage Therapeutics announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
Sage Therapeutics Looks to File NDA for Postpartum Depression Treatment Later This Year biospace
January 15, 2018
Cambridge, Mass.-based SAGE Therapeutics closed out 2017 with stellar results for a mid-stage and late-stage trial aimed at treating two kinds of depression.
5 Biotechs Awaiting FDA Decisions in January 2018 biospace
December 29, 2017
From 1997 through 2013, there was an average of 27 novel drugs approved in the U.S. per year. This year, 46 drugs were approved by the U.S. Food and Drug Administration (FDA)
Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Rela biospace
December 28, 2017
Agios Pharmaceuticals, Inc., a leader in cellular metabolism for the treatment of cancer and rare genetic disorders, today announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA)
Sunovion Announces FDA Acceptance for NDA Review of Dasotraline americanpharmaceuticacreview
November 13, 2017
The NDA submission is supported by multiple placebo-controlled safety and efficacy studies, as well as two long-term studies that assessed the safety of dasotraline in people with ADHD for up to one year.

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