Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of ...

Outlook Therapeutics, Inc. OTLK shares are trading higher Tuesday after the company announced that the U.S. Food and Drug ...

The US Food and Drug Administration (FDA) has announced the start of the next reauthorization process for the Prescription Drug User Fee Act (PDUFA), a major framework under which most new drug ...

The US Food and Drug Administration (FDA) has issued final guidance describing its process for recognizing voluntary consensus standards (VCS) to spur the development of regenerative medicine ...

In June 2025, the US Food and Drug Administration (FDA) announced the Commissioner's National Priority Voucher (CNPV) pilot programme. The regulatory framework allows biotechs and pharma companies who ...

(CNN) — A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children. In ...

As the FDA''s deputy commissioner for food, Diamantas, a former food and drug attorney, led the agency's Human Foods Program ...

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...

The pressure is building for the U.S. Food and Drug Administration (FDA) to take steps to facilitate making more drugs available over-the-counter (OTC) that currently require a prescription. As part ...

Makary's tenure was marked by internal dysfunction at the FDA, leadership turmoil and mounting backlash from drugmakers and physicians on regulatory decisions.

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

FDA's new post-market assessment program takes aim at the preservative BHT and synthetic dough conditioner ADA, continuing the agency's push to reassess food chemicals including the preservative BHA ...