Cancer, rare disease dominate FDA approvals in H1 2026 as AstraZeneca, J&J clean up

 

The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.

Amid unprecedented leadership uncertainty, workforce attrition and myriad controversial decisions, the FDA approved 26 novel drugs in the first half of 2026—seven more than its H1 2025 total.

Among total approvals—novel therapies and label expansions included—the oncology space led the way, followed by therapies for rare diseases and inflammatory and immunological (I&I) indications. While most of the FDA’s cancer nods were for label expansions, the agency did greenlight four new medicines. Corcept Therapeutics,BeOne Medicines, AbbVie and partners Pfizer and Arvinas notched approvals in across multiple cancers.

The rare disease space, meanwhile, celebrated several firsts in H1. Denali Therapeutics’ Avlayah was approved in March as the first treatment for Hunter syndrome to address the disease’s neurological complications, and Regeneron’s gene therapy Otarmeni became the first treatment to target an underlying cause of deafness. It is also Regeneron’s first gene therapy to reach the market.

AstraZeneca also celebrated a successful first half with six FDA greenlights, including for TROP2-directed antibody drug conjugate Datroway in first-line metastatic triple-negative breast cancer. Johnson & Johnson, meanwhile, received happy news from the regulator five times from January to June, including for Icotyde, a daily peptide pill for plaque psoriasis co-developed with Protagonist Therapeutics.

On the mechanistic front, small molecules led the way in terms of total FDA approvals, followed by antibodies then peptides.

https://www.biospace.com/fda/cancer-rare-disease-dominate-fda-approvals-in-h1-2026-as-astrazeneca-j-j-clean-up