The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA approval of ...

More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) ...

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein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

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA nod ...

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 gains for the third consecutive session on the U.S. Food and Drug Administration’s (FDA) approval for ...