Jardiance (empagliflozin) 10 mg has been approved by the FDA to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with… read more.
Following on from a thorough review of the evidence carried out by the MHRA, and recommendation by the Commission on Human Medicines (CHM), the government’s independent expert scientific… read more.
Bristol Myers Squibb announced that the European Commission has granted Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)… read more.
The FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in… read more.
Genentech/Roche announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based… read more.
Sol-Gel Technologies, Ltd. announced that the FDA has approved its first proprietary drug product, Twyneo (tretinoin/benzoyl peroxide) cream, 0.1%/3%, indicated for the treatment of acne vulgaris in adults… read more.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Uptravi (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension… read more.
Almirall S.A. announced that the European Commission (EC) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults. Tirbanibulin… read more.
Moderna, Inc. announced that the Therapeutic Goods Administration (TGA) has granted provisional registration to the COVID-19 Vaccine Moderna in Australia for active immunization to prevent COVID-19 caused by… read more.
Jazz Pharmaceuticals plc announced that the FDA approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults. The company plans… read more.
The FDA has approved pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR),… read more.
In a large real-world study, data published as a pre-print on The Lancet server from over one million individuals assessed the incidence rates of blood clotting disorders of… read more.
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