Bayer announced the FDA has approved Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death,… read more.
Johnson & Johnson announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants…. read more.
PAION AG announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo (remimazolam besylate) in adults for procedural sedation. Byfavo is an ultra-short-acting intravenous… read more.
Seagen Inc. and Astellas Pharma Inc. announced the FDA granted Padcev (enfortumab vedotin-ejfv) regular approval in the U.S., in addition to approving a new indication for adult patients… read more.
Diurnal Group plc announces that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Marketing Authorisation for Efmody (hydrocortisone modified-release hard capsules – development name… read more.
Advicenne announces that the Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Sibnayal (ADV 7103) in the UK, for the treatment of distal renal… read more.
Hansa Biopharma, announced three-year follow-up data in crossmatch positive patients who received imlifidase prior to kidney transplantation. As reported in an article, which has been accepted for publication… read more.
Merck has announced that the FDA has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous… read more.
Merck announced that the company plans to voluntarily withdraw the U.S. accelerated approval indication for Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric… read more.
Lupin Pharmaceuticals announced that the FDA has approved the company’s supplemental New Drug Application (sNDA) to expand the use of Solosec (secnidazole) to include the treatment of trichomoniasis… read more.
Royal Philips announced FDA 510k-clearance of real-time 3D intracardiac echocardiography (ICE) VeriSight Pro catheter which has the potential to improve standard of care for structural heart disease and… read more.
A new study of Soliqua (insulin glargine 100 Units/mL and lixisenatide, (iGlarLixi) met its two primary endpoints and all key secondary endpoints in a head-to-head comparison against premixed… read more.
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