UCB announced Rystiggo (rozanolixizumab-noli) has been approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific… read more.
AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with… read more.
Trevena, Inc. announced new topline Olinvyk data from the ARTEMIS study. The ARTEMIS study was an electronic medical records (EMR) based assessment focused on clinical and health resource… 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 Mircera… read more.
Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced it has submitted a Marketing Authorization Application (MAA) to the European… 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 Refixia…. read more.
AbbVie announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the… read more.
Surmodics, Inc. announced the receipt of FDA approval for the SurVeil drug-coated balloon (DCB). The SurVeil DCB may now be marketed and sold in the U.S. to physicians… read more.
The FDA has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with… read more.
SK Biopharmaceuticals said that Health Canada granted a Notice of Compliance for Xcopri (ingredient: cenobamate), its epilepsy drug, approving its application for marketing authorization in Canada. Paladin Labs,… read more.
Takeda and HUTCHMED (China) Limited announced that results of the Phase III FRESCO2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (CRC) were published in… read more.
Ipsen announced that the FDA has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome (ALGS). Bylvay is… read more.
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