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The narrow FDA labeling makes it so that only a minority of men who could benefit from treatment are considered ‘on-label’ ...
Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA’s June deadline – 51 dogs ...
The drugs are essentially laboratory-made versions of natural antibodies that help the immune system fight off RSV. The FDA ...
Shares of Bayer BAYRY gained 12.1% after the Solicitor General supported a Supreme Court review of its Roundup weedkiller ...
Bayer AG BAYRY announced that pipeline candidate asundexian met primary efficacy and safety endpoints in late-stage OCEANIC-STROKE Study in secondary stroke prevention. Results from the study showed ...
Tarlatamab-dlle received FDA approval for ES-SCLC after showing a 40% reduction in death risk compared with chemotherapy in the DeLLphi-304 trial. The trial demonstrated improved overall survival ...
Sevabertinib received accelerated FDA approval for HER2 TKD-mutant nonsquamous NSCLC, showing a 71% ORR in the SOHO-01 trial. The treatment demonstrated a tolerable safety profile, with diarrhea as ...
To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the type ...
This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...
To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the ...