Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

Merck MRK announced that the FDA has accepted its regulatory filing seeking approval for the subcutaneous (under the skin or ...

Shares of the Redwood City-based Soleno Therapeutics climbed 38% — the biggest one-day gain since September 2023 — to their ...

Soleno Therapeutics ($SLNO) stock skyrocketed up over 42% this past week on news that it has achieved a significant milestone ...

Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has been a ...

The FDA recently approved the first treatment in nearly 30 years for acute stroke, and the agency also approved a novel drug ...

UBS has received regulatory approval to fully own Beijing-headquartered UBS Securities, the Swiss bank said on Friday, ...

Novartis' Fabhalta receives FDA approval for C3 glomerulopathy, expanding its kidney disease portfolio as global regulatory ...

The FDA approved neoadjuvant Imfinzi, gemcitabine and cisplatin, followed by adjuvant Imfinzi after radical cystectomy in ...

A Prescription Drug User Fee Act (PDUFA) target action date for apitegromab has been set for Sept. 22, 2025.

The FDA launches sweeping changes to food safety rules that could transform grocery aisles nationwide as untested ingredients ...

With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment ...