A Prescription Drug User Fee Act target date of August 12, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) ...
The designation was supported by data from the multicenter, double-blind, placebo-controlled phase 3 PROMIS-I study. The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation ...
Insmed has won U.S. Food and Drug Administration approval of Brinsupri as the first and only treatment for the chronic lung disease non-cystic fibrosis bronchiectasis. Insmed on Tuesday said the FDA ...
BRIDGEWATER, N.J., Aug. 12, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform ...
Armata Pharmaceuticals, Inc., a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that ...
CHAPEL HILL, N.C. & MIAMI--(BUSINESS WIRE)--Renovion and COPD Foundation Joint Release – Renovion, Inc. has announced that the first patient has been enrolled in a Phase 2 clinical study evaluating ...
Shares of Bridgewater, N.J.-based Insmed Inc. (NASDAQ:INSM) closed at $28.88, up $8.34, or 40.6%, on positive top-line results from the global, randomized, double-blind placebo-controlled phase II ...
A year of research emphasizes the significance of collaboration, standardized approaches, and targeted therapies in rare pulmonary diseases. This article was originally published at HCP Live. It has ...
CHAPEL HILL, N.C. & MIAMI--(BUSINESS WIRE)--Renovion and the COPD Foundation have announced the creation of a new partnership to accelerate the development of a novel therapy for the treatment of ...
BRIDGEWATER, N.J., Sept. 7, 2020 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, ...
— Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage — — BRINSUPRI 10 mg and 25 mg Doses ...
Please provide your email address to receive an email when new articles are posted on . The FDA granted breakthrough therapy designation to colistimethate sodium powder for nebulization solution to ...
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