Targeted Oncology

FDA Issues CRL to NDA for Dasynoc in CML and ALL

The FDA has issued a complete response letter (CRL) to a new drug application (NDA) for Dasynoc for the treatment of chronic ...
Managed Healthcare Executive

AbbVie Submits NDA for Parkinson’s Disease Drug, Tavapadon

Tavapadon is an investigational, novel, once-daily treatment option for Parkinson’s disease, which currently affects more ...
Business Insider

Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program

MINNEAPOLIS, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U.S.
Business Insider

Myovant Sciences Submits New Drug Application (NDA) to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids

NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year ...
Benzinga.com

What's Going On With Mid-Cap Cancer-Focused Verastem Oncology Stock On Friday?

One dose-limiting toxicity, febrile neutropenia (low white blood cell count), was observed in the dose level 1 cohort. FDA has accepted Verastem's plan to submit the clinical module in the second half ...
Nasdaq

Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

BURLINGTON, Mass., May 10, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central ...