FDA Approves Boostrix for Whooping Cough Prevention October 10, 2022 The approval was supported by study data indicating that the vaccine has 78 percent efficacy. Read More
UK Authorizes Eli Lilly’s Olumiant for Severe Alopecia Areata October 5, 2022 The FDA approved the drug for this indication in June. Read More
Santhera Seeks EU Authorization for DMD Drug October 4, 2022 The drug candidate met its primary endpoint in a phase 2b study. Read More
Otsuka Gains Accelerated Approval for Bile Duct Cancer October 4, 2022 The study met its primary endpoint with an objective response rate of 42 percent. Read More
BioMarin Resubmits BLA for Hemophilia A Drug Candidate October 3, 2022 The company expects the FDA to respond by the end of October. Read More
Amylyx’s ALS Drug, Relyvrio, Snags FDA Approval October 3, 2022 Amylyx has received full approval for its amyotrophic lateral sclerosis (ALS) drug, now dubbed Relyvrio (AMX0035). Read More
Avastin Biosimilar Gets FDA Approval for Six Types of Cancer September 30, 2022 Vegzelma has also been approved in the EU, the UK and Japan. Read More
Regeneron and Sanofi’s Dupixent Approved for Prurigo Nodularis September 30, 2022 The expanded approval was based on positive results from two phase 3 clinical trials. Read More
Pharming Gets Priority Review for Leniolisib September 29, 2022 The FDA has set a target decision date for the NDA of March 29, 2023. Read More
Argenx Submits BLA for Generalized Myasthenia Gravis September 28, 2022 Argenx uses Halozyme Therapeutics’ drug delivery technology. Read More
Eli Lilly’s Retevmo Gains FDA Approval for Two Indications September 23, 2022 The FDA has also granted the drug an accelerated approval for certain adult patients with locally advanced or metastatic solid tumors. Read More
EC Approves AstraZeneca’s Tezspire for Severe Asthma September 22, 2022 The drug was developed in a collaboration with AstraZeneca and Amgen that dates back to 2012. Read More