USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

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

Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva

Positive data for Roche multiple sclerosis injection

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

Novartis reports data from trial of IgA nephropathy treatment

IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide

Lupin launches first generic version of Oracea in US

Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients

Zydus receives approval for the name 'Usnoflast' as recommended name for ZYIL1 from WHO International Non-proprietary Names

Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor discovered at Zydus

lpca Laboratories enters into Technology Transfer Agreement with Omexa Formulary

Under this agreement, lpca will grant to Omexa a non-exclusive right to research, develop, manufacture and market an anti-cancer biosimilar for the global market

Celanese and Secarna Pharmaceuticals collaborate for RNA research for antisense therapies

Biocon Biologics secures US market entry date for Bmab 1200

The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA

GSK completes acquisition of Aiolos Bio

The acquisition of Aiolos includes AIO-001, a potentially best-in-class, long-acting antithymic stromal lymphopoietin (TSLP) monoclonal antibody