FDA approval

Imagine scaling a mountain only to later lose digits or an entire hand to the unforgiving ravages of frostbite. For climbers, explorers, adventurous backcountry skiers, and even those caught in unexpected winter storms, severe cold exposure carries a devastating risk — amputation. Today,  thanks to a potentially landmark FDA approval, the prospect of losing one’s…

Compass Pathways has named biotech exec Daphne Karydas to its board. Karydas is the president and chief financial officer of Flare Therapeutics Inc., which is developing drug discovery programs targeting transcription factors for cancer and other diseases. Signs point to a potential FDA approval of psilocybin and MDMA under strict controls in the coming years,…

Respiratory syncytial virus (RSV) is a common cause of severe lower respiratory tract infections like pneumonia and bronchiolitis in infants and young children. Traditionally there have been no approved treatments for RSV infections, with care being largely supportive. But the landscape is quickly changing. The FDA recently approved Beyfortus (nirsevimab), the first immunoprophylactic to prevent…

Tokyo-based Astellas Pharma has won FDA approval for Veozah (fezolinetant) 45 mg to treat moderate to severe vasomotor symptoms associated with menopause. The non-hormonal menopause treatment represents the first neurokinin 3 receptor antagonist to win FDA backing for vasomotor symptoms, which afflict 60-80% of women during menopause. The approval was based on the BRIGHT SKY…

The state of California has established a $50 million collaboration over a decade with the generic drug manufacturer Civica. The goal of the collaboration is to create affordable state-branded generic insulin. Qualified individuals may obtain a 10-mL vial of generic insulin for $30 or less. California plans to provide a pack containing five prefilled 3…