Musculoskeletal Disorders

Stealth’s elamipretide gains FDA advisory committee support for Barth syndrome

Stealth Biotherapeutics' new drug application (NDA) for elamipretide has received a favourable vote from the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for Barth syndrome.

Allay grants acute pain management drug license to Japan’s Maruishi Pharmaceutical

Allay Therapeutics has announced a licensing agreement granting Maruishi Pharmaceutical exclusive rights to develop and commercialise ATX101, a non-opioid upivacaine-based drug, and other ultra-sustained analgesic implantable drug candidates for acute pain, in Japan.

Bio-Thera Solutions’ BAT1806 receives China NMPA approval

Bio-Thera Solutions has received approval for the biosimilar of Actemra (tocilizumab), BAT1806, from the National Medical Products Administration (NMPA) of China.

US FDA accepts Santhera, ReveraGen’s vamorolone NDA to treat DMD

Santhera Pharmaceuticals and ReveraGen BioPharma have announced the acceptance of vamorolone’s new drug application (NDA) for filing by the US Food and Drug Administration (FDA) to treat Duchenne muscular dystrophy (DMD).

Stealth receives FDA orphan drug designation for elamipretide to treat DMD

Stealth BioTherapeutics has received Orphan Drug Designation from the US Food and Drug Administration (FDA) Office of Orphan Products Development for elamipretide to treat Duchenne muscular dystrophy (DMD) patients.