Orforglipron is the first new molecular entity cleared under the FDA's Commissioner's National Priority Voucher (CNPV) pilot ...

The FDA approved a high-dose nusinersen regimen for spinal muscular atrophy, offering pharma teams key insights into dose ...

Add Yahoo as a preferred source to see more of our stories on Google. Draft guidance from the FDA would allow companies to scale back on the studies and trials needed to prove that a biosimilar ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency ...

Overcoming common challenges with today’s biologics, such as developing devices for high-concentration subcutaneous ...

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of ...

IXICO PLC (LSE:IXI, OTC:PHYOF, FRA:PYPB), the neuroscience imaging and analytics company, is raising up to £10.5 million ...

When patient safety, regulatory approval and real-world effectiveness are on the line, AI can't act autonomously.

Phase II Clinical Study of Adebrelimab and Bevacizumab Combined With Cisplatin/Carboplatin in Patients With Triple-Negative Breast Cancer With Brain Metastases (ABC Study) Receipt of previous ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...