Drug Approval | December 12, 2025
Apitoria Pharma receives 3 observations from USFDA for Unit-V
The company will respond to the US FDA within the stipulated timelines
The company will respond to the US FDA within the stipulated timelines
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
Valorum will advance the commercialization and distribution of Armlupeg in the United States
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
The agreement allows Biocon Biologics to commercialize both its Denosumab biosimilars (Vevzuo and Evfraxy) in Europe starting December 2, 2025
The deal aims to address long-standing imbalances in pharmaceutical trade while boosting investment and innovation on both sides of the Atlantic
This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA
Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
The study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio
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