The FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are… read more.
PTC Therapeutics, Inc. announced that the European Commission (EC) has decided not to adopt the CHMP’s negative opinion of January 24, 2024 on the annual renewal of the… read more.
Sandoz, the global leader in generic and biosimilar medicines, announced that the European Commission (EC) has granted marketing authorization for Wyost (C) and Jubbonti (denosumab), the first and… read more.
Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to Humira (adalimumab), in the… read more.
-Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab-irmb (U.S. brand name:Leqembi)… read more.
Zai Lab Limited announced that the National Medical Products Administration (NMPA) in China has approved the New Drug Application (NDA) for Augtyro (repotrectinib) for the treatment of adult… read more.
Researchers will delve into emerging research in diabetes, obesity, reproductive health and other aspects of hormone health during the Endocrine Society’s ENDO 2024 news conferences June 1-4. The… read more.
Ascendis Pharma A/S announced that the FDA notified the Company that information submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon… read more.
Shionogi & Co., Ltd. announced that its pivotal, double-blind, randomized, placebo-controlled global Phase III study (SCORPIO-HR) did not meet its primary endpoint of a statistically significant reduction in… read more.
When compared with pre-surgical (neoadjuvant) chemotherapy only, adding perioperative immunotherapy before and after surgery significantly improves event-free survival in patients with resectable early-stage non-small cell lung cancer (NSCLC),… read more.
At the European Congress on Obesity in Venice, investigators unveiled results from an analysis published in Nature Medicine evaluating Wegovy’s weight loss benefits over four years. With this… read more.
A new technique for 3D printing medication has enabled the printing of multiple drugs in a single tablet, paving the way for personalised pills that can deliver timed… read more.
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