Akili Interactive announced topline data from an open-label study (STARS-ADHD Adjunctive) of AKL-T01 for the treatment of attention deficit hyperactivity disorder in children with or without use of stimulants.
Taro Pharmaceuticals announced the voluntary recall of 1 lot of lamotrigine 100mg tablets to the consumer level due to cross-contamination with a small amount of enalapril maleate.
The FDA has approved lemborexant for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.
The Food and Drug Administration (FDA) has approved Ubrelvy (ubrogepant tablets; Allergan), the first oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine with or without aura in adults.
The FDA has accepted for review the resubmitted New Drug Application (NDA) for apomorphine sublingual film (APL-130277; Sunovion) for the treatment of OFF episodes in patients with Parkinson disease (PD).
The FDA has a supplemental New Drug Application for capsaicin 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
The FDA has approved the supplemental New Drug Application for riluzole oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes for the treatment of ALS.
The FDA has granted accelerated approval to Vyondys 53 (golodirsen; Sarepta Therapeutics) injection for the treatment of Duchenne muscular dystrophy.
Positive data announced from the pivotal part 2 of the SUNFISH trial that evaluated the safety and efficacy of risdiplam in adult and pediatric patients with Type 2 or Type 3 SMA.
The FDA has granted Fast Track designation to neflamapimod (EIP Pharma) for the treatment of dementia with Lewy bodies (DLB).
