Category - New Drug Applications

New Drug Applications

Kyowa Hakko Kirin Announces FDA Notification of PDUFA Action Date Extension for Mogamulizumab

8 years ago

New Drug Applications

Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)

8 years ago

New Drug Applications

U.S. FDA Grants Priority Review to Astellas’ New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

8 years ago

New Drug Applications

Circassia Announces Submission of Duaklir (aclidinium and formoterol) New Drug Application

8 years ago

New Drug Applications

Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression

8 years ago

New Drug Applications

FDA Accepts Larotrectinib New Drug Application and Grants Priority Review

8 years ago

New Drug Applications

Palatin Technologies Announces FDA Acceptance for Review of Bremelanotide NDA

8 years ago

New Drug Applications

Intra-Cellular Therapies Initiates Rolling Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia

8 years ago

New Drug Applications

Evoke Announces FDA Submission of New Drug Application for Gimoti

8 years ago

New Drug Applications

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

8 years ago