Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration ...
Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food ...
The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, ...
Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number ...
Q4 2024 Earnings Conference Call February 25, 2025 8:00 AM ETCompany ParticipantsMichael Dale - Chairman and Chief ...
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental biologics licence ...
Precigen (PGEN) announced the FDA has accepted the company’s biologics license application, or BLA, for PRGN-2012, an investigational ...
Merck (MRK) announced the FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for keytruda – ...
Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review ...
The firm submitted data from a Phase III study showing the combination improved outcomes compared to Opdivo and chemo alone.
Nivolumab plus ipilimumab is being reviewed by the FDA as a first-line treatment for advanced colorectal cancer, with a ...
The application was based on results from the three-arm Phase 3 CheckMate -8HW study.