Approvals
The headlines showed a robust tally of new drug approvals from the US FDA in 2025, but cracks are beginning to show that could turn into fissures in the year ahead.
The European Medicines Agency has recommended new uses for nine approved medicines, including Incyte's immunotherapy Zynyz which is poised to become the first EU treatment for squamous cell carcinoma of the anal canal.
Accelerated approvals of novel products rebounded in 2025 as drug development adapted to major pathway changes enacted in the FDA Omnibus Reform Act, but pending applications suggest a potentially bigger impact outside oncology in 2026.
The European Medicines Agency said that Sanofi’s Rezurock should be approved on a conditional basis for patients with chronic graft-versus host disease after reconsidering its initial decision not to recommend the drug.
Sponsors also want efficacy supplement action packages released after redaction as part of a proposal to increase first-cycle approvals.
The FDA starts 2026 with 55 novel agents under review, which are detailed in Pink Sheet's interactive chart.
In 2025, 43 drugs containing new active substances (NASs) were approved in the EU, and 2026 has already seen three NAS approvals with more expected soon. Also, for 1H 2026, the EU regulator has received 84 letters of intent for marketing applications for new drugs, of which 58 contain NASs.
Review times for novel agents approved in 2025 stayed remarkably steady, hugging PDUFA timelines, maintaining high approval volumes, and foreshadowing a new debate over whether ultra‑fast, politically driven reviews will result from the Commissioner's National Priority Voucher program.
Interactive infographic tracking submission to approval for all 58 novel agents approved by US FDA in 2025
The European Medicines Agency has not “always fared favorably” compared to other countries such as the US when it comes to drug approval timelines, but the reform of the EU pharma legislation is a key opportunity to “think out of the box,” says the agency’s head of therapeutics areas.
More complete response letters were issued than approvals for novel neuroscience candidates in 2025. Orphan neurology therapies were hit the hardest.
Zidebactam/cefepime, Wockhardt's novel antibiotic treatment for resistant Gram-negative infections, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Wayrilz, Sanofi's treatment for immune thrombocytopenia.
Pink Sheet's annual listing of novel agents and the review designations they carried
While the volume of applications was one of the highest in the decade, a high rate of complete response letters winnowed the pool to an approval total near the 10-year average of 56. The approval total for 2025 is very close to the 61 new molecular entities and novel biologics approved in 2024.
The European Medicines Agency has said that Anavex’s Alzheimer’s candidate should not be authorized for use in the EU due to safety and efficacy concerns. Seven other products, including two new cancer drugs, received positive opinions.
The first approval under the Commissioner's National Priority Voucher, a re-introduction of domestic production of an antibiotic, took two months to clear, but the timeline will be more challenging for the three pending CNPV applications with efficacy claims.
Several global products have been granted approval recommendations in Japan, while two Japan-originated drugs received a preliminary nod in their home country after being approved first elsewhere through licensees.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Lynkuet, Bayer's treatment for moderate to severe vasomotor symptoms associated with menopause or endocrine therapy for breast cancer.
A new reliance pathway under which regulators will rely on each other’s assessment reports strengthens the goals of key continental health initiatives, including the newly formed African Medicines Agency.