fda

J&J's table-integrated OTTAVA robot completed all 30 gastric bypass procedures without conversion and met safety endpoints, advancing its FDA De Novo application.

Fresh 52-week safety data presented at ATS 2026 reinforce cytisinicline's profile ahead of a June 20 FDA decision that could bring the first new smoking cessation drug to US patients since 2006.

The FDA cleared an IND for UHeart, a 10-gene-edited pig heart, opening a single-center phase 1/2/3 trial that will enroll up to two patients with end-stage heart failure before any expansion.

NEJM publishes Phase 1/2 data for oral RAS(ON) inhibitor daraxonrasib (~30% ORR, 90% disease control in pretreated patients); FDA issues 'safe to proceed' for EAP on May 1, now available for eligible metastatic PDAC patients.

Regenxbio's gene therapy RGX-202 met the primary endpoint of its pivotal Phase III AFFINITY DUCHENNE trial, with 93% of participants reaching the microdystrophin expression threshold.

The May 8 sBLA approval extends efgartigimod's label to MuSK, LRP4 and triple-seronegative gMG patients after the 119-patient ADAPT SERON trial hit its MG-ADL endpoint with a 3.35-point improvement at week 4 (p=0.0068).

The agency is asking patients, clinicians and researchers to nominate FDA-approved drugs that could be relabeled for new indications, including those backed by case reports or AI-generated preclinical evidence.

First-quarter results from both partners show CASGEVY past 500 treatment starts, a US filing for ages 5 to under 12, and CRISPR Therapeutics' in vivo pipeline advancing across four liver-directed programs.

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

The FDA announced two proof-of-concept real-time cancer trials and opened public comment on a broader pilot program, betting that cloud and AI-mediated data flow can compress drug review timelines.

A new joint program from FDA and CMS would issue a proposed Medicare coverage decision the same day a breakthrough device wins FDA authorization, aiming to cut total time-to-coverage from roughly a year or more to about two months.

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.