Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Medicines Agency will update the Dupixent (dupilumab) summary of product characteristics (SmPC) adding long-term safety results for adults with… read more.
AstraZeneca’s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes… read more.
Novo Nordisk presented data showing that an investigational 2.0 mg dose of Ozempic (semaglutide) provided statistically significant and superior reductions in blood sugar (HbA1C) compared with Ozempic 1.0… read more.
AstraZeneca and HUTCHMED’s Orpathys (savolitinib) has been granted conditional approval in China to treat patients with non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who… read more.
Merck Inc., announced that the pivotal Phase III KEYNOTE-826 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with… read more.
AstraZeneca and MSD’s Koselugo (selumetinib) has been granted conditional approval in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with… read more.
The European Commission has granted marketing authorization for Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure), Boehringer… read more.
On 25 June 2021 the Therapeutic Goods Administration (TGA) granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making… read more.
LEO Pharma announced that the European Commission (EC) has approved Adtralza (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy…. read more.
Amneal Pharmaceuticals announced the FDA has accepted for review the Biologics License Application (BLA) for bevacizumab biosimilar for the treatment of metastatic colorectal cancer, in combination with intravenous… read more.
Gilead Sciences, Inc. announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge… read more.
Mallinckrodt Plc announced that the FDA has approved StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns… read more.
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