Drug Approval | September 02, 2025
FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
Enters the high growth vitamins, minerals and supplements segment for adults, paediatrics, and animal health
Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season
Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market
WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals
Triggering global regulatory submissions this year for the treatment of obesity
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
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