[ad_1] Approval based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT® this year, with four indications overall RARITAN, N.J., Sept. 17, 2024 /PRNewswire/ — Johnson […]
Tag: FDA Approval
Senhwa Biosciences Announces IND Submission to US FDA for Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors sponsored by NCI
[ad_1] TAIPEI and SAN DIEGO, Sept. 17, 2024 /PRNewswire/ — Senhwa Biosciences, Inc. (TPEx: 6492), , a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced that an […]
Designación de terapia innovadora para los comprimidos sublinguales de Sanbexin
[ad_1] – Designación de terapia innovadora para los comprimidos sublinguales de Sanbexin otorgada por la Administración de Alimentos y Medicamentos de Estados Unidos NANJING, China, 16 de septiembre de 2024 /PRNewswire/ — El 2 de […]
TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease
[ad_1] The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program1,2,3,4,5 TREMFYA® is now approved for the treatment […]
Novavax 2024-2025 Formula COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.
[ad_1] Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S. Novavax’s vaccine is the only protein-based option available in the U.S. for use in individuals aged 12 and older […]