Merck Inc. announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy… read more.
Kyowa Kirin Co., Ltd. has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an… read more.
The FDA has granted approval to Octapharma USA for Octagam 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment… read more.
Rates of the very rare clotting disorder, thrombosis with thrombocytopenia syndrome (TTS), following a second dose of Vaxzevria are comparable to the background rate in an unvaccinated population… read more.
BeiGene, Ltd. a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that Brukinsa (zanubrutinib) has… read more.
Genentech, a member of the Roche Group announced results from the final analysis of the Phase IIIb STASEY study , which confirm the favorable safety profile of Hemlibra… read more.
Merck Inc., has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for soluble guanylate cyclase (sGC) stimulator Verquvo (vericiguat). In the… read more.
Interim results from a Phase 1/IIa sub-study published in the New England Journal of Medicine (NEJM) demonstrated that both humoral (antibody) and cellular (T-cell) immune responses generated by… read more.
GlaxoSmithKline plc announced positive headline results from five studies of the Phase III ASCEND programme, evaluating the efficacy and safety profile of daprodustat, an investigational oral hypoxia-inducible factor… read more.
Takeda Pharmaceutical announced results from two final analyses from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study Open-label Extension (OLE), which evaluated the long-term safety (primary endpoint)… read more.
Eli Lilly and Company and Incyte announced that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action date for the supplemental new drug application… read more.
Merck Inc., announced the FDA has approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes… read more.
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