The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Jubbonti, intended for the… read more.
Bristol Myers Squibb announced that the European Commission (EC) has granted approval to Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple… read more.
Bristol Myers Squibb announced the Phase III CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC) who… read more.
CSL Vifor announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of… read more.
– Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, announced the FDA has… read more.
Johnson & Johnson announced that the FDA Oncologic Drugs Advisory Committee (ODAC) recommends Carvykti (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple… read more.
NovaBay Pharmaceuticals, Inc. and Eyenovia, Inc. announced the signing of a co-promotion agreement to commercialize prescription ophthalmic products to eyecare professionals across the U.S. Under the agreement, NovaBay… read more.
BeiGene, Ltd. announced that the FDA has approved Tevimbra (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after… read more.
Santhera Pharmaceuticals is pleased to note the launch of Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in the United States by Catalyst Pharmaceuticals, Inc. the… read more.
Bristol Myers Squibb announced that the FDA approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial… read more.
The HeartMate Touch Communication System monitors patients who have an implantable HeartMate 3 Left Ventricular Assist Device. The HeartMate Touch Communication System works with the HeartMate System Controller…. read more.
Vanda Pharmaceuticals Inc. announced that on March 4, 2024, it received a Complete Response Letter (CRL) from the FDA as part of its ongoing review of Vanda’s supplemental… read more.
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