The FDA announced the approval of Omlyclo (omalizumab-igec) as the first biosimilar to reference Xolair (omalizumab). The biosimilar was also approved with interchangeability status and is the first… read more.
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union (EU) as monotherapy for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has… read more.
Santen Pharmaceutical Co., Ltd. announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for Ryjunea (:STN 1012701). Ryjunea is a… read more.
Allurion Technologies, Inc. announced initial results on the combination of the Allurion Program with low-dose GLP-1 therapy to optimize muscle mass and GLP-1 adherence. 52 patients treated with… read more.
Valneva SE, a specialty vaccine company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Deqsiga, intended for replacement therapy in people… read more.
Late-breaking results from Eli Lilly and Company and Incyte found adolescent patients (ages 12 to under 18) with severe alopecia areata (AA) treated with once-daily, oral baricitinib 4… read more.
Abbott announced it has received CE Mark in Europe for the Volt PFA System to treat patients battling atrial fibrillation (AFib). With the earlier-than-expected CE Mark, Abbott has… read more.
Indivior PLC announced that the FDA has approved label changes for Sublocade (buprenorphine extended-release ) including a rapid initiation protocol and alternative injection sites, marking a significant advancement… read more.
Novo Nordisk announced that the FDA approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients… read more.
GSK plc announced that the FDA has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary… read more.
Pfizer Inc. announced positive results from the Phase III TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor… read more.
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