Drug Approval | December 05, 2025
Lupin receives FDA’s tentative approval for Siponimod tablets
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
Senores Pharmaceuticals is poised to accelerate its presence in the Asia-Pacific region
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor
The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration
Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data
Presbyopia, the age-related loss of near vision, could soon be treated successfully
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 drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway
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