Tag: BeiGene

FDA approves BeiGene’s TEVIMBRA for esophageal cancer treatment

businessnewstoday- March 18, 2024

In a notable advancement in the oncology sector, BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a globally recognized oncology company, has received approval from ... Read More

BeiGene’s BRUKINSA gains accelerated FDA approval for follicular lymphoma treatment

businessnewstoday- March 8, 2024

In a significant development for patients with relapsed or refractory follicular lymphoma, BeiGene, Ltd. has announced the U.S. Food and Drug Administration (FDA) has granted ... Read More

CHMP recommends approval for BeiGene’s tislelizumab in ESCC treatment

businessnewstoday- July 22, 2023

BeiGene, a global biotechnology firm, has revealed that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for ... Read More

BeiGene gets Brukinsa FDA approval for chronic lymphocytic leukemia

Raghuram Kadari- January 21, 2023

BeiGene has secured the approval of the US Food and Drug Administration (FDA) for the company’s Brukinsa (zanubrutinib) for the treatment of adult patients with ... Read More

Amgen gets breakthrough therapy status for sotorasib in China

pharmanewsdaily- January 31, 2021

Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National ... Read More

Chinese regulator accepts NDA of BeiGene’s pamiparib in ovarian cancer

pharmanewsdaily- July 19, 2020

BeiGene said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of ... Read More

Amgen to take 20.5% stake in Chinese biotech company BeiGene for $2.7bn

pharmanewsdaily- November 5, 2019

US biopharma company Amgen has signed an all-cash deal to acquire a 20.5% stake in Chinese biotech company BeiGene for about $2.7 billion, as per ... Read More