Beta3-Adrenergic Receptor Antagonist Fast-Tracked for Decompensated Heart Failure
The Food and Drug Administration has granted Fast Track designation to APD418 (Arena Pharmaceuticals) for the treatment of decompensated heart failure.
The Food and Drug Administration has granted Fast Track designation to APD418 (Arena Pharmaceuticals) for the treatment of decompensated heart failure.
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.
The FDA has granted Fast Track designation to bomedemstat (IMG-7289; Imago BioSciences) for the treatment of essential thrombocythemia, a myeloproliferative disorder characterized by high platelet counts.
The FDA has approved the New Drug Application (NDA) for Numbrino (cocaine hydrochloride nasal solution; Lannett) for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
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 Ayvakit (avapritinib; Blueprint Medicines Corporation), a tyrosine kinase inhibitor, for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
DBV Technologies announced positive topline results from the phase 3 PEOPLE trial of Viaskin Peanut for the treatment of peanut-allergic children aged 4 to 11 years.
The Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection; Astellas Pharma) for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients aged <4 months.
In addition to a panel of experts, for the first time, the guideline was developed with the help of patients, emphasizing the importance of shared decision-making.
The Food and Drug Administration has granted 510(k) clearance to TOMi Scope (PhotoniCare) as an imaging tool for visualization of the human tympanic membrane and middle ear space.