Measles Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides

SHELTON, CONNECTICUT / ACCESS Newswire / February 10, 2026 / NanoViricides, Inc., a publicly traded company (NYSE ...
CURE

FDA Accepts Ivonescimab Application for EGFR Lung Cancer

The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
FierceBiotech

FDA accelerates Stealth Bio's rare disease application with a decision slated for next month

The FDA has accepted Stealth BioTherapeutics’ new drug application for its ultrarare disease candidate, providing a planned decision date of Sept. 26. The timeline is surprising since the agency ...
Morningstar

Ascelia Pharma Announces FDA Acceptance of Orviglance New Drug Application for Review

MALMÖ, SE / ACCESS Newswire / November 15, 2025 / Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the ...
Hosted on MSN

Q&A: New drug being reviewed by the FDA to treat Parkinson's disease

The U.S. Food and Drug Administration is reviewing a new Parkinson's disease drug called tavapadon that could give people with the disease more control over their movements. Subscribe to our ...

Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for ...

Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have ...