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FDA Approves Biosimilar Interchangeable Insulin Treatment for Diabetes americanpharmaceuticalreview
July 30, 2021
The FDA approved the first interchangeable biosimilar product, Mylan’s Semglee (insulin glargine-yfgn). Semglee (insulin glargine-yfgn) is both biosimilar to and interchangeable with Lantus (insulin glargine).
FDA Authorizes New Standalone Treatment for COVID-19 americanpharmaceuticalreview
July 30, 2021
The U.S. FDA revised the Emergency Use Authorization (EUA) for baricitinib (sold under the brand name Olumiant) now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older ...
FDA expands EUA for Lilly-Incyte’s baricitinib as Covid-19 monotherapy pharmaceutical-technology
July 30, 2021
The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for Eli Lilly and Incyte’s drug, baricitinib, for Covid-19 treatment with or without remdesivir.
Biocon Biologics and Viatris receive US FDA approval for maiden interchangeable biosimilar Semglee expresspharma
July 30, 2021
Interchangeable designation allows substitution at the pharmacy counter for Lantus across the US to help increase access to medicines for people living with diabetes.
FDA accepts application for Roche’s Faricimab expresspharma
July 30, 2021
If approved, Faricimab would be the first and only medicine designed to target two distinct pathways that drive retinal diseases that can cause vision loss.
Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) drugs
July 30, 2021
Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab.
McCormick Recalls Seasonings Over Salmonella Risk drugs
July 30, 2021
McCormick & Co. on Wednesday announced the recall of several of its popular seasonings because of potential Salmonella contamination, according to the U.S. Food and Drug Administration.
FDA Approves First Biosimilar Insulin Product drugs
July 30, 2021
The first interchangeable biosimilar insulin product has been approved by the U.S. Food and Drug Administration, providing patients with a cost-effective option for treating diabetes, the agency announced Wednesday.
GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps firstwordpharma
July 30, 2021
GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps.
Everest Medicines Receives Pediatric and Rare Severe Disease Priority Review Designation from Taiwan, China FDA for Sacituzumab Govitecan-Hziy in Metastatic Triple-Negative Breast Cancer prnasia
July 29, 2021
Everest Medicines announced today that the Taiwan, China Food and Drug Administration (FDA) has granted Pediatric and Rare Severe Disease Priority Review Designation for sacituzumab govitecan-hziy (SG).

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