This Goopy Seaweed Slurry Could Make Its Way Into Everything You Eat and Wear
A startup called Marine Biologics is breaking down seaweed into its base components so they can be used for a range of ...
MPR1d
Obinutuzumab Under Review for Treatment of Lupus Nephritis
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva®) for the treatment of ...
Contract Pharma1d
FDA Accepts Roche’s sBLA for Lupus Nephritis Treatment
Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License ...
Genentech gets FDA acceptance for its Lupus treatment's license application
Genentech, a Roche Group company(OTCQX:RHHBY) said on Wednesday that the U.S. FDA accepted the company’s supplemental ...
Infectious Disease Advisor1d
Gene Therapy Gets Priority Review for Recurrent Respiratory Papillomatosis
The FDA has accepted for Priority Review the BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis.
Lupus Foundation of America1d
FDA Accepts Supplemental Biologics License Application for Gayzva for Treatment of Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for ...
The Joplin Globe1d
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
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 ...
Managed Healthcare Executive2d
FDA Accepts Amneal’s BLA for Two Denosumab Biosimilars
The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.
Capricor Therapeutics Shares Rise on FDA Priority Review
Capricor Therapeutics' shares rose after its biologics license application for deramiocel to treat a form of muscular dystrophy was given priority review by the Food and Drug Administration. Shares ...
Capricor announces FDA acceptance, Priority Review for deramiocel BLA
Capricor Therapeutics (CAPR) announced the U.S. Food and Drug Administration has accepted for review its Biologics License Application seeking ...
EconoTimes3d
FDA Reviews GSK’s Depemokimab for Asthma and CRSwNP Treatment
The U.S. Food and Drug Administration (FDA) has accepted GlaxoSmithKlines (NYSE:GSK) biologics license application for ...
Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration
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 ...