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 ...

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...

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 ...

The U.S. could soon see its biggest shift in sunscreen regulation in over 25 years as the FDA considers approving a new UV ...

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

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 ...

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 ...

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

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 ...

It takes about 14 years to get a new drug approved by the Food and Drug Administration. That leaves drug companies about six years of exclusive sales until their 20-year patent expires, and they ...