The US Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson’s Stelara, from South Korea’s Celltrion. 18 December 2024
AstraZeneca and development partner Daiichi Sankyo have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer. 24 December 2024
French specialty vaccine company Valneva has entered into an exclusive license agreement for its single-shot chikungunya vaccine that enables supply of the vaccine in Asia with Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses. 24 December 2024
Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024
US pharma major Bristol Myers Squibb has announced positive results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase III trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 24 December 2024
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
Texan biopharma firm XBiotech has announced a suspension of its clinical program in rheumatology, after its Phase II trial for rheumatoid arthritis failed to meet the primary endpoint. 23 December 2024
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024
New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review. 23 December 2024
French pharma major Sanofi says it has entered into a new chapter of the collaboration with South Korean firm SK bioscience in pneumococcal vaccines, with an expanded agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations. 23 December 2024
The Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for the treatment of early Alzheimer’s disease (AD). 5 December 2024
Privately-held Certa Therapeutics, a biotech developing precision therapies for fibrotic diseases, has acquired fellow Australian firm OccuRx. 19 December 2024