Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and development in immuno-oncology, announced that the company has been granted a patent (Patent No. US 11,299,550 B2) on its anti-CD73 antibodies by the United States Patent and...
Following the Centers for Medicare & Medicaid Services’ (CMS) decision to limit the coverage of Biogen’s controversial Alzheimer’s drug Aduhelm to individuals participating in clinical trials, the Alzheimer’s community is now waiting in anticipation for other...
Amphastar Pharmaceuticals, Inc.,announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (“ANDA”) for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe. Ganirelix acetate...
As more clinical trials shift toward decentralized models, utilizing methods that enable remote monitoring and self-reported patient data are allowing for a patient-centric drug development process that does not require in-person clinical visits. Nevertheless, many...
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance...
BeiGene, Ltd., a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that marketing authorization applications (MAA) for tislelizumab,...
Curium announced that its generic version of DaTscan (Ioflupane I 123 Injection) was approved on March 30, 2022, by the U.S. Food and Drug Administration (FDA). Ioflupane I 123 Injection is a single-photon emission computed tomography (SPECT) brain imaging agent used...
After wrapping up March with a flurry of PDUFA dates, the U.S. Food and Drug Administration has a more leisurely calendar for the first three weeks of April, at least in terms of drug approvals. BioXcel Therapeutics, based in New Haven, Conn., has a target action date...
The world’s first “human challenge” trial in which volunteers were deliberately exposed to the coronavirus has found that symptoms had no effect on how likely an infected person is to pass the disease on to others. The findings underscore the...
JW Therapeutics, an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products...
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