drug-approval

Otsuka's Simtriyo (centanafadine) becomes the first approved norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, backed by four Phase 3 trials, with a boxed warning and DEA scheduling still pending.

The FDA on May 13 cleared Taiho Oncology's Inqovi combined with venetoclax as the first fully oral treatment for older or unfit AML patients, replacing injection-based clinic visits.

The FDA granted accelerated approval to Hepcludex (bulevirtide-gmod) on May 22, 2026, making it the first treatment cleared for chronic hepatitis delta virus infection in the United States.

Vepdegestrant becomes the first PROTAC ever approved by the FDA, treating ESR1-mutated advanced breast cancer after one prior endocrine therapy.

Compass Pathways, Usona Institute, and Otsuka-acquired Transcend Therapeutics have been selected for FDA's Commissioner's National Priority Voucher program for psilocybin and methylone, six days after President Trump's executive order on serious mental illness.

Axsome Therapeutics' AXS-05 faces its FDA verdict on April 30 for Alzheimer's disease agitation, backed by four Phase 3 trials but complicated by one failed study.

The FDA cleared doravirine/islatravir on April 21, completing a development program that was halted in 2021 over lymphocyte counts and restarted at a lower dose.

Novo Nordisk's Awiqli reduces basal insulin injections from 365 to 52 per year, winning FDA approval after a 2024 rejection over manufacturing and safety concerns.

Johnson & Johnson's Icotyde (icotrokinra), a once-daily oral peptide that blocks the IL-23 receptor, became the first targeted oral therapy to match biologic-level skin clearance in moderate-to-severe plaque psoriasis, marking a potential paradigm shift away from injectable treatments.

Takeda's oveporexton, an oral drug that restores the brain chemical missing in narcolepsy type 1, has received FDA priority review after two Phase 3 trials showed it brought patients to near-normal wakefulness and cut cataplexy episodes by more than 80 percent.

The FDA has delayed its decision on Eli Lilly's oral obesity pill orforglipron from March 28 to April 10, alongside delays for three other drugs in the new expedited review program.

Japan's health ministry has conditionally approved two iPS cell-derived drugs, marking the first time regenerative medicines built from induced pluripotent stem cells will reach patients commercially.