FDA approves next generation Gallan implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. Abbott
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Seagen Inc. announced full results from the pivotal phase II MOUNTAINEER trial , which showed Tukysa (tucatinib) in combination with trastuzumab was well-tolerated with durable responses in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC).
Innovent Biologics, Inc. and Eli Lilly and Company announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
Basilea Pharmaceutica Ltd., announced that its license partner, Pfizer Inc., has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the intravenous formulation of Cresemba (isavuconazole) for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis. This is the second approved formulation for Cresemba in China, in addition to the oral formulation for invasive aspergillosis and invasive mucormycosis.