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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.
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 ...
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.
Complete Response Letter from FDA for Barhemsys drugs
May 20, 2019
Complete Response Letter from FDA for Barhemsys.
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.
FDA hits Acacia with another rejection, cites manufacturer issues pharmatimes
May 09, 2019
FDA hits Acacia with another rejection, cites manufacturer issues.
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 ...
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 …
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.
Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application drugs
April 18, 2019
Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application.

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