Cancer, rare disease dominate FDA approvals in H1 2026 as AstraZeneca, J&J clean up
July 9, 2026 |
1 min read |
<a href="https://healthylife7.com/three-ways-to-get-used-to-exercising-in-the-heat/” title=”Three Ways to Get Used to Exercising in the Heat”>Heather McKenzie
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
FDA
Despite chaos and churn, FDA decisions hold mostly steady in H1 2026
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
July 6, 2026
· 8 min read
· Tristan Manalac
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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
RegulatoryFDACancerRare diseases
Heather McKenzie
