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 ...
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.
MPR2d
Emapalumab Gets Priority Review for HLH/MAS in Still Disease
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for emapalumab-Izsg for use ...
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 ...
Business Wire2d
Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA
“We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalization ...
CURE3d
FDA Accepts Ordspono Resubmission in R/R Follicular Lymphoma Treatment
The FDA has accepted the resubmission of the BLA of Ordspono for review in relapsed/refractory follicular lymphoma following previous systemic therapy.
Share Prices3d
GSK says US FDA accepts two depemokimab indication submissions
(Alliance News) - GSK PLC on Monday said the US Food & Drug Administration has accepted for review the biologics license application for depemokimab in two indications - for asthma with type 2 ...
Star Tribune4d
Minnesota cannabis agency begins accepting license applications for pot businesses
A cannabis plant grows under indoor lighting Jab. 21 at the Prairie Island Indian Community’s cannabis cultivation site in Welch. (Alex Kormann/The Minnesota Star Tribune) ...
Pharmaceutical Technology on MSN6d
FDA accepts Sobi’s Gamifant application for HLH/MAS treatment
The US Food and Drug Administration has accepted Sobi’s supplemental biologics licence application for Gamifant ...