Pacira BioSciences, Inc. announced that the FDA has approved its supplemental new drug application (sNDA) to expand the Exparel (bupivacaine liposome injectable suspension) label to include administration in… read more.
Boston Scientific Corporation announced the close of its acquisition of Relievant Medsystems Inc., a company that offers the only FDA -cleared Intracept Intraosseous Nerve Ablation System, a therapy… read more.
CorMedix Inc. announced that the FDA has approved DefenCath (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited… read more.
Health Canada has approved the gene therapy Hemgenix (etranacogene dezaparvovec) for treating adults with hemophilia B who rely on routine prophylactic therapies to prevent or reduce bleeding episodes…. read more.
Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin). Tecentriq (atezolizumab)…. read more.
Phathom Pharmaceuticals, Inc. announced the FDA has approved Voqenza (vonoprazan) tablets 10 mg and 20 mg, a novel potassium-competitive acid blocker (PCAB), as a new treatment for adults… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Talzenna…. read more.
Eli Lilly’s Mounjaro is recommended for use in Europe for the treatment of obesity. The recommendation comes the same week the drug was approved for obesity treatment in… read more.
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for the Company’s medicine… read more.
On 9 November 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.
GSK plc has announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the National Medical Products… read more.
OPKO Health, Inc. presented late-breaking clinical data on Rayaldee extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia. These data, presented in a… read more.
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