Seagen Inc. and Astellas Pharma Inc. announced positive topline results from the Phase III EV-302 clinical trial (also known as KEYNOTE-A39) for Padcev (enfortumab vedotin-ejfv) in combination with… read more.
Medtronic plc announced CE (Conformité Européenne) Mark approval for its new all-in-one, disposable Simplera continuous glucose monitor (CGM) featuring a simple, two-step insertion process. The company’s newest no-fingerstick… read more.
Novartis announced that it has completed its divestment of ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up… read more.
Sandoz, a global leader in generic and biosimilar medicines, announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko (natalizumab), developed by… read more.
Leqvio (inclisiran), became the first siRNA therapy for dyslipidemia approved in Japan. The drug was approved for familial and non-familial hypercholesterolemia and is intended for patients who are… read more.
Chugai Pharmaceutical Co., Ltd. announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Phesgo combination for Subcutaneous Injection MA, IN… read more.
Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe… read more.
Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has approved Jardiance (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular… read more.
The FDA has accepted for review a biologics license application (BLA) seeking the approval of tislelizumab (Tevimbra) for use in the frontline treatment of patients with unresectable, recurrent,… read more.
On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.
Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking… read more.
GSK plc announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the European Commission has authorised… read more.
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