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.

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 Roche (RHHBY), announced that the FDA has accepted the company’s supplemental biologics license application for Gazyva ...

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 ...

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.

The state’s Office of Cannabis Management (OCM) kicked off its license application process earlier this week. The office laid out a new timeline in December after announcing the cancellation of ...

Biologics are medications made from antibodies that prevent certain proteins in the body from causing inflammation. Different types target different proteins. They’re usually injected or infused ...