Category - New Drug Applications

New Drug Applications

Novartis Announces FDA Filing Acceptance and Priority Review of AVXS-101, a One-Time Treatment Designed to Address the Genetic Root Cause of SMA Type 1

7 years ago

New Drug Applications

UroGen Pharma Initiates Rolling Submission of New Drug Application (NDA) for UGN-101 for the Treatment of Low-Grade Upper Tract Urothelial Cancer

7 years ago

New Drug Applications

Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis

7 years ago

New Drug Applications

FDA Accepts Filing of New Estrogen-free Oral Contraceptive Slinda (drospirenone) Developed by Exeltis

7 years ago

New Drug Applications

DBV Technologies Announces Submission of Biologics License Application for Viaskin Peanut to the U.S. Food and Drug Administration

7 years ago

New Drug Applications

Glenmark Pharmaceuticals Announces New Data Presentations on Ryaltris at the ACAAI Annual Scientific Meeting 2018

7 years ago

New Drug Applications

Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration

7 years ago

New Drug Applications

Sage Therapeutics Receives Notification of PDUFA Extension for Zulresso (brexanolone) Injection

7 years ago

New Drug Applications

Evolus Receives Conditional FDA Acceptance of Jeuveau Brand Name

7 years ago

New Drug Applications

FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

7 years ago