Category - New Drug Applications

New Drug Applications

Kala Pharmaceuticals Announces New Drug Application for Inveltys (KPI-121 1%) Has Been Accepted for Review by the U.S. Food and Drug Administration

8 years ago

New Drug Applications

Mallinckrodt Completes Stannsoporfin New Drug Application Filing

8 years ago

New Drug Applications

Trevena Announces FDA Acceptance for Review of New Drug Application for Olinvo (oliceridine) Injection

8 years ago

New Drug Applications

Achaogen Announces FDA Acceptance of New Drug Application with Priority Review for Plazomicin for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections

8 years ago

New Drug Applications

Tetraphase Pharmaceuticals Announces Submission of New Drug Application to FDA for Eravacycline for the Treatment of Complicated Intra-Abdominal Infections (cIAI)

8 years ago

New Drug Applications

Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for Azedra (iobenguane I 131) in Pheochromocytoma and Paraganglioma

8 years ago

New Drug Applications

Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot

8 years ago

New Drug Applications

Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism

8 years ago

New Drug Applications

Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

8 years ago

New Drug Applications

FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

8 years ago