Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced European CE mark approval of the Varipulse Platform for the… read more.
SpringWorks Therapeutics, Inc. announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of… read more.
Mirum Pharmaceuticals, Inc. announced that Hepatology published an analysis demonstrating a statistically significant improvement in six-year event-free and transplant-free survival in patients with Alagille syndrome (ALGS) treated with… read more.
Arcutis Biotherapeutics, Inc. and Sato Pharmaceutical Co., Ltd., a leading pharmaceutical company, announced that the companies have entered into a strategic collaboration and licensing agreement for the development,… read more.
BeiGene, Ltd. announced that the FDA has accepted a Biologics License Application (BLA) for Tevimbra (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients… read more.
FibroGen, Inc. announced that FibroGen and AstraZeneca have agreed to terminate the U.S./RoW roxadustat collaboration agreement entered into on July 30, 2013, under which AstraZeneca held development and… read more.
Alvotech announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT 04, a biosimilar to… read more.
Genentech, a member of the Roche Group, announced data from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating the efficacy and… read more.
Vertex Pharmaceuticals announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of Kalydeco (ivacaftor)… read more.
Rigel Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to acquire the U.S. rights to Gavreto (pralsetinib) from Blueprint Medicines Corporation. Gavreto is a once… read more.
MHLW (Japan) approved on February 9 Nippon Boehringer Ingelheim’s SGLT2 inhibitor Jardiance (empagliflozin) for the treatment of chronic kidney disease (CKD) </p. Jardiance has been available in Japan… read more.
Regeneron Pharmaceuticals, Inc. announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of… read more.
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