INX-315, a CDK2 inhibitor, received FDA fast track designation for patients with CCNE1-amplified platinum-resistant ovarian ...

An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...

Fast Track designation highlights potential of INX-315 to address unmet need for patients with recurrent advanced/metastatic ...

BioRestorative Therapies Receives FDA Fast Track Approval For BRTX-100 To Treat Chronic Lumbar Disc Disease 16.04.2025 / 16:21 CET/CEST The issuer is solely responsible for the content of this ...

The FDA has granted approval to Akeso's differentiated programmed cell death protein 1 (PD-1) monoclonal antibody, penpulimab ...

LUND, SE / ACCESS Newswire / April 29, 2025 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class i ...

Penpulimab is approved for multiple indications in China, but this marks the first US approval for the novel monoclonal ...

At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 target date, according to two people with direct knowledge of the ...

Novavax Says Its COVID-19 Shot Is on Track for Full FDA Approval After Delay WASHINGTON (AP) — Novavax's closely watched COVID-19 vaccine is on track for full approval after additional ...