MedImpact Holdings Inc., based in San Diego, has announced the availability of an unbranded biosimilar ustekinumab-aekn at a lower cost compared to...
Vanda Pharmaceuticals has won an appeals court judgment requiring the FDA to reconsider its application for Hetlioz as a treatment for jet lag diso...
Stealth BioTherapeutics has resubmitted its New Drug Application (NDA) for elamipretide to the FDA for the treatment of Barth syndrome. The resubmi...
Soligenix, Inc. has received orphan drug designation from the FDA for its drug SGX945, intended for the treatment of Behçet's Disease. This designa...
Atara Biotherapeutics Inc., an immunotherapy company based in Thousand Oaks, has resubmitted its application for the drug Ebvallo to the U.S. Food ...
AI simulations are transforming the landscape of clinical trials and drug development by introducing 'virtual patients.' These computational models...
The U.S. Food and Drug Administration (FDA) has approved Tonix Pharmaceuticals Holding Corp.'s drug Tonmya for the treatment of fibromyalgia in adu...
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Izalontamab Brengitecan, a bispecific antibody-drug con...
The FDA has approved Novo Nordisk's weight-loss drug Wegovy for treating metabolic dysfunction-associated steatohepatitis (MASH) in adults. This ap...
AB&B has announced that both the U.S. Food and Drug Administration (FDA) and China's Center for Drug Evaluation (CDE) have approved the Investigati...