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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
Leqvio works by improving the liver’s ability to prevent the production of a protein that plays a role in keeping circulating cholesterol levels high. Read More
The FDA has approved Novartis’s new drug application (NDA) for its cholesterol-lowering drug Leqvio (inclisiran) after rejecting the NDA a year ago because of manufacturing concerns. Read More
High-quality evidence was lacking for most of the COVID-19 diagnostics, medical devices and drugs the FDA has granted Emergency Use Authorization (EUA) since the start of the pandemic, claimed researchers at Israel’s Tel-Aviv University in a provocative analysis in the journal JAMA Internal Medicine. Read More