This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
Breakthrough Therapy designation for pain associated with DPN granted by FDA
Around 7% of the Indian population suffers from IBS
Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market
NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections
Interim analysis of an ongoing 156-week extension study supports long-term safety, tolerability and efficacy of atogepant 60 mg to prevent chronic and episodic migraine
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide
Global Phase-3 study initiation expected in the second half of 2024
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