Shanghai Henlius and Organon Submit Biosimilar Application for Denosumab to FDA
Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly...
Amgen
FDA Extends Review of Amgen’s Lumakras for KRAS G12C mCRC Treatment to January 2025
On October 18, FirstWord reported that the U.S. FDA has extended the review period for...
MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant...
Amgen’s Tepezza Receives Approval in Japan for Treating Thyroid Eye Disease
Amgen (NASDAQ: AMGN), a prominent biotechnology company based in the U.S., has announced that its...
Amgen to Establish New Site in Hyderabad, India, with Focus on Technology and Digital Innovation
Amgen (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has announced strategic plans...
Amgen Halts Development of Claudin 6-Targeting BiTE Immune Therapy AMG 794
Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has decided to...
Amgen Secures Commercialization Rights for Avacopan in Asia and Latin America
Amgen (NASDAQ: AMGN), a leading biopharmaceutical company, has entered into a licensing agreement with CSL...
Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received...
Amgen’s Prolia Secures NMPA Approval for Treating Glucocorticoid-Induced Osteoporosis in High-Risk Patients
Biopharmaceutical giant Amgen has received marketing approval from China’s National Medical Products Administration (NMPA) for...
Novartis Halts Development of KRAS Inhibitor Opnurasib Due to Competitive Market
Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has reportedly halted the development of its Phase...
Amgen’s Bkemv Becomes First Biosimilar to Challenge AstraZeneca’s Soliris with FDA Approval
Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the...
Sandoz Receives European Commission Approval for Biosimilars Wyost and Jubbonti
The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX:...
Alvotech and Dr. Reddy’s Partner to Challenge Amgen’s Denosumab with Biosimilar AVT03
Amgen’s (NASDAQ: AMGN) dominance in the bone treatment market with its blockbuster drugs Xgeva and...
FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN)...
Amgen’s Tezspire Shows Promise in Phase IIa COPD Trial, Reduces Exacerbations
Amgen (NASDAQ: AMGN), a multinational biopharmaceutical company, has this week announced results from a Phase...
Qilu Pharmaceutical Gets NMPA Green Light for Generic Romiplostim for ITP Treatment
The National Medical Products Administration (NMPA) in China has granted marketing approval to Qilu Pharmaceutical...
Dr. Reddy’s Launches Biosimilar Versavo in UK to Challenge Roche’s Cancer Therapy Avastin
Dr. Reddy’s Laboratories (NYSE: RDY), a prominent Indian pharmaceutical company, has launched its biosimilar Versavo...
Amgen Reports Positive Results for Otezla in Pediatric Psoriasis Trial
Amgen (NASDAQ: AMGN) provided an update last week on a late-stage trial evaluating its PDE4...
Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical...
Amgen’s Q4 2023 Results Showcase 9% YOY Growth, 18 Drugs Hit Record Sales
Biopharmaceutical giant Amgen (NASDAQ: AMGN) has reported its financial results for Q4 2023, announcing annual...