Drug Approval | September 21, 2021
U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
Clindamycin Phosphate Foam, 1% is the generic version of Evoclin Foam, 1%
Klifovet’s client base comprises the world’s top animal health and nutrition companies as well as many promising startups
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
First participants enrolled in Phase 1 clinical trial of combination NanoFlu/NVX-CoV2373 vaccine with Matrix-M adjuvant. The Phase 1/2 study will also evaluate immunogenicity and safety
The medicine is now approved for eight indications across five different types of cancer in China.
It adds Rezurock (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD)
Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)
This is Omeza’s first Rx product and the first drug/device combination matrix of its kind for chronic wound care
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