Disc Medicine earns a Strong Buy rating as bitopertin advances for EPP/XLP, with FDA review fast-tracked and strong funding.

NDA 1 Application Form 2025: The Union Public Service Commission (UPSC) has started accepting online applications for the National Defence Academy (NDA) at upsc.gov.in for 406 vacancies at the ...

The FDA has accepted for review Chiesi’s New Drug Application (NDA) for their investigational maintenance treatment for ...

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 ...

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.

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CTx-1301 for the treatment of attention deficit/hyperactivity disorder (ADHD) in children and adults.

Celcuity expects to complete a rolling NDA submission for gedatolisib under the FDA RTOR program by Q4 2025. Click here to ...

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

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 ...

Unicycive Therapeutics Inc UNCY provided an update based on recent interactions with the FDA concerning the company's New Drug Application (NDA) for lanthanum dioxycarbonate (LDC), previously known as ...