BioPharma Dive

GSK’s RSV vaccine wins broader FDA clearance

The approval represents a win in what’s been a difficult regulatory environment of late for vaccine makers, and could boost ...
Morningstar

Sunshine Biopharma Gains FDA-Equivalent Clearance in Canada for Domperidone to Treat Cancer-related Nausea

FORT LAUDERDALE, FL / ACCESS Newswire / October 28, 2025 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a leading pharmaceutical company focused on innovative and affordable healthcare ...
Seeking Alpha

GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-3650, an NK Cell Engager for Treatment of CD33+ Leukemia

SAN FRANCISCO, CALIFORNIA, June 27, 2024 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's ...
Seeking Alpha

GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-5550 TriKE®, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors ...

Unaudited proforma cash balance as of January 31, 2026 of approximately $9 million anticipated to extend cash runway through Q4 2026 SAN FRANCISCO, CALIFORNIA, Feb. 03, 2026 (GLOBE NEWSWIRE) -- GT ...
WSPA

Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA

SHENZHEN, China, May 28, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND ...
ksn.com

Benitec Biopharma Receives FDA Clearance of the IND for BB-301 for the Treatment of Oculopharyngeal Muscular Dystrophy

HAYWARD, Calif., June 26, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel ...