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An appraisal committee for the UK’s National Institute for Health and Care Evidence (NICE) has recommended against National Health Service (NHS) use of Lynparza (olaparib), AstraZeneca’s blockbuster cancer drug, for treating men with previously treated hormone-resistant metastatic prostate cancer with BRCA1 or BRCA2 mutations. Read More
The FDA has approved Xeris Biopharma’s Recorlev (levoketoconazole) for treating hypercortisolemia in adults with Cushing’s syndrome who are unable to undergo surgery. Read More
Besides the FDA approval, tralokinumab has seen a stellar year, earning regulatory approvals in the EU, UK, Canada and the United Arab Emirates. Read More
One of the four FDA approvals was Enzyvant Therapeutics’ Rethymic (allogeneic processed thymus tissue-agdc), which was approved for pediatric congenital athymia. Read More
Amylyx Pharmaceuticals has scored a priority review by the FDA for AMX0035 (sodium phenylbutyrate and taurursodiol) as a treatment for amyotrophic lateral sclerosis (ALS). Read More
With 2021 nearly over, LEO Pharma has scored a big victory with Adbry (tralokinumab-ldrm), earning the FDA’s blessing for treating moderate-to-severe eczema (atopic dermatitis). The approval marks the Denmark-based company’s first U.S. biologic. Read More