Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris ...

Emapalumab-Izsg is under the FDA’s Priority Review for hemophagocytic lymphohistiocytosis/macrophage activation syndrome in Still disease.

A startup called Marine Biologics is breaking down seaweed into its base components so they can be used for a range of ...

Genentech, a Roche Group company(OTCQX:RHHBY) said on Wednesday that the U.S. FDA accepted the company’s supplemental ...

The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for ...

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License ...

GSK (GSK) announced the US Food and Drug Administration, FDA, has accepted for review the Biologics License Application, BLA, for the use of ...

The US Food and Drug Administration has accepted Sobi’s supplemental biologics licence application for Gamifant ...

Outlook Therapeutics has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...

We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential ...

The firm's biologics license application for TLX250-CDx was granted priority review and a decision is expected in August.

Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number ...