Bionpharma's etravirine tablet for HIV/AIDS, developed on a continuous manufacturing platform, got Abbreviated New Drug ...
The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...
January is Cervical Cancer Awareness Month, and health officials say cervical cancer is one of the most preventable cancers.
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.
The U.S. Food and Drug Administration (FDA) approved six new therapies in December 2025 for blood cancers, prostate cancer, ...
Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...
After a tumultuous journey filled with delays and rejection, the FDA has approved Stealth BioTherapeutics’ treatment for the ultrarare disease Barth syndrome, marking the peptide as the first therapy ...
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
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