FDA grants traditional approval to Keytruda for HER2-positive GEJ
On March 19, the Food and Drug Administration granted traditional approval to pembrolizumab, or Keytruda, marketed by Merck (MRK), with ...
Zacks Investment Research on MSN15h
FDA Accepts RDY & ALVO's Prolia & Xgeva Biosimilar BLA for Review
Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...
Zacks Investment Research on MSN15h
JNJ's Nipocalimab Gets FDA's Fast Track Tag for Sjogren's Disease
Johnson & Johnson JNJ announced that the FDA has granted a Fast Track designation (“FTD’) to its investigational drug, ...
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Florida House panel takes up restrictions on water fluoridation and food labeling
A subcommittee advanced a package dubbed the "Florida Farm Bill." Targets include "any additive" to water "for health-related ...
MPR1d
Baqsimi Approved for Severe Hypoglycemia Treatment in Younger Patients
The Food and Drug Administration (FDA) has expanded the approval of Baqsimi (glucagon) nasal powder to include the treatment of severe hypoglycemia in ...
Alvotech and Dr. Reddy’s gets FDA nod for Biologic License Application for AVT03
Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03. Read more here.
Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...