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FDA Approvals Outrun Staff Cuts: 23 Novel Drugs Mark Best First Half in Three Years

on July 06, 2026

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The FDA approved 23 novel drugs in the first half of 2026, marking the best first half for new drug approvals in three years despite significant staff reductions.

These approvals covered oncology, infectious diseases, metabolic and endocrine disorders, neurology, and rare genetic diseases, underscoring continued innovation in the pharmaceutical pipeline.

Notable approvals include vepdegestrant and sonrotoclax for oncology indications, ensitrelvir for COVID-19 prophylaxis, and several therapies for rare genetic disorders such as Menkes disease and Hunter syndrome.

Sources:

Novel Drug Approvals for 2026 - FDA

ASCO 2026 highlights accelerating ADC field with Topo1 inhibitor ...

FDA new drug approvals in Q1 2026

The Drug Update: Recent drug approvals, winter 2026 edition

25 Anticipated FDA Approvals for the First Quarter of 2026

FDA Novel Drug Approvals 2026 Q1: Full List & Insights

FDA New Drug Approvals Plummet… Growing Regulatory ...

FDA Drug Reviews Held Steady in 2025 Despite Historic Staffing ...

FDA Approvals in Oncology: January-March 2026 | Blog | AACR

Fewer drugs, more chaos: One year under the new FDA

2026 Orphan Drugs: PDUFA Dates and FDA Approvals - CheckRare

FDA Drug Approval Decisions: June and July 2026

New Drugs and Therapies That May Be Approved in 2026 - GoodRx

42 FDA Approvals for the First Quarter of 2026 - Guideline Central

FDA approves 16 new drugs in first half, lowest in eight years

Communicable Diseases Drug Approval First Half Hereditary Diseases Infrequent Metabolic Diseases Neoplasms New Staff United States Food and Drug Administration

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