June 23, 2022 —Novartis today announced the US Food and Drug Administration (FDA) granted accelerated approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of adult and pediatric patients 6 years……
June 2, 2022 --Genentech, a member of the Roche Group, recently announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old wi……
May 25, 2022-Sanofi and its partner Regeneron jointly announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE)……
May 23, 2022- The U.S. Food and Drug Administration (FDA) approved Mounjaro™ (tirzepatide) injection, Eli Lilly and Company's (NYSE: LLY) new once-weekly GIP (glucose-dependent insulinotropic……
Apr. 20, 2022-Takeda today announced that the Phase 3 SHP643-302 study evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO® (lanadelumab) in patients 2 to ……
Marketing Authorisation Holder:EU guidance states that the ultimate responsibility for the performance of a medicinal product over its lifetime in relation to its safety, quality and efficacy, lies with the Marketing Aut……
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