BioBrief’s Friday episode covers a regulatory-heavy day in biopharma, with two meaningful FDA oncology decisions landing against a weak biotech tape.

In today’s BioBrief:

• Enhertu — The FDA approved AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate in two early-stage HER2-positive breast cancer settings, including adjuvant use after residual invasive disease.
• Tecentriq and Signatera — Roche’s Tecentriq was approved for ctDNA-positive muscle-invasive bladder cancer after cystectomy, alongside Natera’s Signatera CDx companion diagnostic.
• Aardvark Therapeutics — The FDA placed ARD-101 under a full clinical hold after cardiac safety concerns, resetting the outlook for the company’s Prader-Willi syndrome program.
• Market pulse — Biotech un ...