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Blueprint Medicines Submits NDA for Avapritinib
americanpharmaceuticalreview
June 20, 2019
Blueprint Medicines has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST) ...
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Blueprint Medicines Submits New Drug Application to U.S. Food and Drug Administration for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
drugs
June 17, 2019
Blueprint Medicines Submits New Drug Application to U.S. Food and Drug Administration for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST.
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FDA Accepts NDA for Triple Combination Tablet for Adults with Type 2 Diabetes
americanpharmaceuticalreview
June 06, 2019
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and ...
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Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla
drugs
May 21, 2019
Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla.
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Complete Response Letter from FDA for Barhemsys
drugs
May 20, 2019
Complete Response Letter from FDA for Barhemsys.
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Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019
drugs
May 15, 2019
Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019.
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FDA hits Acacia with another rejection, cites manufacturer issues
pharmatimes
May 09, 2019
FDA hits Acacia with another rejection, cites manufacturer issues.
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Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Intravenous Contepo (fosfomycin) for injection
drugs
May 08, 2019
Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections ...
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FDA accepts NDA for ALKS 5461 for major depressive disorder
europeanpharmaceuticalreview
April 25, 2019
The FDA has accepted for review the New Drug Application for ALKS 5461, a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder …
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Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US
drugs
April 18, 2019
Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US.