FierceBiotech

Stealth Bio submits third FDA application for rare disease candidate

After an FDA rejection in May, Stealth BioTherapeutics has resubmitted a new drug application for its investigational treatment designed to treat an ultra-rare genetic disease. This is the biotech’s ...

Andrew Hillman Grant Opens 2026 Biotech Application Cycle in Dallas

Andrew Hillman Grant for Biotech Introduces National Opportunity for Undergraduate Talent to Explore the Future of ...
Business Wire

Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI ® (ciltacabtagene autoleucel)

SOMERSET, N.J.--(BUSINESS WIRE)--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat ...
Morningstar

Harbour BioMed and Kelun-Biotech Announce NMPA Approval of IND Application for HBM7575/SKB575 for the Treatment of Atopic Dermatitis

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, March 9, 2026 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of ...
Nasdaq

Krystal Biotech Announces FDA Clearance of Investigational New Drug Application for KB408 for the Treatment of Type 1 Alpha-1 Antitrypsin Deficiency

PITTSBURGH, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development, and ...