U.S. Food and Drug Administration Archives

Can Zetagen’s ZetaMet Phase 2a data change how metastatic breast cancer bone lesions are treated?

Find out how Zetagen’s ZetaMet Phase 2a data may reshape treatment of metastatic breast cancer bone lesions.

Find out how Takeda’s pediatric Entyvio review could change biologic treatment choices in ulcerative colitis and Crohn’s disease.

Find out how FDA approval for Gilead Sciences’ Hepcludex could reshape chronic hepatitis delta virus treatment in the U.S.

Find out how United Therapeutics’ FDA-cleared UHeart trial could reshape xenotransplantation for end-stage heart failure patients.

Find out how Tempus’ tumor-only xT CDx FDA approval could expand precision oncology testing and reshape solid tumor profiling.

Find out how Pharming’s Joenja sNDA resubmission could reopen the FDA pathway for younger children with APDS.

Adrabetadex faces a longer FDA review in infantile-onset NPC. The delay could shape rare-disease drug standards in 2026.

ANKTIVA already has an NMIBC foothold. The harder test is whether FDA reviewers accept extrapolation into papillary-only disease.

Bayer needs a new cardiovascular growth engine. Asundexian’s FDA priority review now tests whether Factor XIa can move from promise to practice.

Bayer has FDA momentum in HER2-mutated lung cancer. The harder test is whether HYRNUO can move earlier without stronger survival data.