Category - New Drug Applications
Pain Therapeutics Resubmits New Drug Application for Remoxy ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain
U.S., EU and Japan Health Authorities Accept Regulatory Submissions For Review Of Pfizer’s Third-generation ALK Inhibitor Lorlatinib
Verastem Submits NDA to FDA for Duvelisib for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
Alnylam Announces FDA Acceptance of New Drug Application (NDA) and Priority Review Status for Patisiran, an Investigational RNAi Therapeutic for the Treatment of Hereditary ATTR (hATTR) Amyloidosis
Paratek Completes Submission of New Drug Applications to U.S. FDA for Oral and Intravenous Omadacycline for Pneumonia and Skin Infections
Alkermes Submits New Drug Application To U.S. FDA For ALKS 5461 For The Adjunctive Treatment Of Major Depressive Disorder
Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-121 Acne Treatment In Lotion Form
Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease