For how we live.
Talazoparib was already approved for castration-resistant disease. On 26 October the FDA cleared it earlier, in the hormone-sensitive, HRR-mutated setting, where TALAPRO-3 halved the risk of radiographic progression.
On 16 October the FDA converted pembrolizumab's accelerated approval for mutation-heavy solid tumours to full approval, but narrowed it: the qualifying threshold moved from 10 to 13 mutations per megabase.
The FDA logged two linked Class II recalls on 21 October: Teva pulled more than 240,000 cartons of its 5 mg nausea-and-reflux tablet, and a repackager pulled its own, both for foreign tablets or capsules mixed in.
Teva's subcutaneous depot is built to avoid the post-injection sedation that hobbled the first olanzapine shot. It cleared the FDA on 8 October; in the phase 3 SOLARIS trial it beat placebo on symptoms at eight weeks.
Approved on 24 June under NDA 220436, the Avyxa Holdings product is a ready-to-infuse form of the NK-1 blocker fosaprepitant, cleared on studies of an earlier intravenous version of the drug.
Twenty-four healthy volunteers received all three drugs in a crossover trial. At 30 mg, 2C-B matched MDMA's intensity and produced psilocybin-like states, without psilocybin's anxiety.