Three years after its initial FDA approval, Roche has made up for an early disadvantage with its blood cancer drug Lunsumio ...

On Monday evening, the Food and Drug Administration approved Novo Nordisk’s high-dose oral formulation of semaglutide for ...

Samsung Bioepis Co. Ltd. has announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO', ...

Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma (TM), a ...

Approval based on global Phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung ...

While the expanded approval fulfills an unmet meet in postmenopausal women, its benefits are marginal in that population.

The action follows mounting scientific evidence linking the injectable contraceptive medication to an increased risk for meningioma.

Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthmaApproval based on global phase 3 program ...

Extended-release buprenorphine is approved as a once-monthly subcutaneous injection for the treatment of moderate-to-severe ...

The FDA has granted approval to a subcutaneous formulation of mosunetuzumab (Lunsumio VELO; Genentech/Roche) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma ...

Merck and Daiichi Sankyo acknowledged a "voluntary pause" in the phase III program for the investigational antibody-drug conjugate ifinatamab deruxtecan following a higher-than-expected number of ...

The FDA approved depemokimab as an add-on maintenance treatment in patients aged at least 12 years with severe asthma and an ...