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By PharmaCompass
2026-02-26
Impressions: 670
Our update for new drug approvals by the US Food and Drug Administration (FDA) in the first half (H1) of 2025 had pointed out how upheavals at the agency had impacted its functioning, with drug approvals dropping by 24 percent.
While the turbulence didn’t subside, approvals picked up considerably in the second half (H2) of 2025. FDA’s Center for Drug Evaluation and Research (CDER) approved 30 new drugs in H2 (as against 16 in H1), taking the total number of approvals for 2025 up to 46. This is an 8 percent drop compared with 50 approvals CDER had granted in 2024.
During the year, CDER saw four new chiefs come and go — Jacqueline Corrigan-Curay (Jan-July 2025), George Tidmarsh (July-Nov 2025), Richard Pazdur (Nov-December 2025) and Tracy Beth Høeg (December 2025-present). In addition, the agency endured thousands of retrenchments. The US Department of Health and Human Services (HHS), under Health Secretary Robert F. Kennedy Jr., enforced funding cuts and changes in approval processes, especially for vaccines.
Overall, we have been witnessing a steady drop in drug approvals by CDER — it approved 55 new drugs in 2023, 50 in 2024 and, 46 in 2025.
Of the 46 new approvals in 2025, 20 were classified as first-in-class (therapies that use a new and unique mechanism of action), out of which 13 were approved in H2 2025. Overall, CDER approved 32 chemical entities and 14 biologics in 2025.
In comparison, approvals by Health Canada and authorizations by the European Medicines Agency (EMA) rose in 2025. The EMA authorized 69 new therapies, up from 64 in 2024. Health Canada approved 46 new therapies in 2025, as compared with 28 in 2024.
FDA’s Center for Biologics Evaluation and Research (CBER) approved 21 biologics in 2025, compared with 13 in 2024, of which eight were notable new drugs.
Interestingly, both CDER and CBER rejected more drugs last year — 43 applications were rejected, including those for new drugs, supplemental filings, generics and biosimilars, as opposed to 29 in 2024.
View New Drug Approvals in 2025 with Estimated Sales (Free Excel Available)
Blockbuster drug approvals drop by 60%, European drugmakers score more FDA nods
Interestingly, European companies won many more approvals for new products than their counterparts in the US. GSK and Novartis achieved three approvals each, while Merck, Boehringer Ingelheim and Bayer AG won two approvals each.
The first-in-class drugs approved in H2 are: Insmed's Brinsupri (brensocatib), Ionis's Dawnzera (donidalorsen), Stealth Bio's Forzinity (elamipretide), Boehringer's Jascayd (nerandomilast), UCB's Kygevvi (doxecitine and doxribtimine), Bayer's Lynkuet (elinzanetant), Chimerix's Modeyso (dordaviprone), Innoviva's Nuzolvence (zoliflodacin), Arrowhead's Redemplo (plozasiran), Novartis' Rhapsido (remibrutinib), Otsuka's Voyxact (sibeprenlimab-szsi), Sanofi's Wayrilz (rilzabrutinib) and Omeros' Yartemlea (narsoplimab-wuug).
View New Drug Approvals in 2025 with Estimated Sales (Free Excel Available)
Insmed’s Brinsupri approved for chronic lung disease; Novartis’ Rhapsido okayed for urticaria
As has been the trend, the field of oncology saw the maximum drug approvals (15), followed by rare diseases and disorders (7) and immunology (4). Three categories — infections and infectious diseases, respiratory diseases and cardiology/vascular diseases — saw three drug approvals each.
Among the first-in-class approvals was Insmed’s Brinsupri (brensocatib), the first treatment for non-cystic fibrosis bronchiectasis, a chronic lung disease. Nature has estimated peak sales of US$ 6.3 billion for this treatment. Brinsupri was approved by the EMA in November.
Another notable approval was granted to Novartis’ Rhapsido (remibrutinib), approved to treat the skin condition chronic spontaneous urticaria in adults who remain symptomatic despite treatment with antihistamines. Rhapsido is the first oral alternative to injectable treatments and has 2030 sales forecasts of US$ 2.1 billion. Novartis is also testing the drug for other immune conditions.
A new drug that is estimated to bring in the maximum sales is Merck’s Keytruda Qlex, a subcutaneous formulation of pembrolizumab plus berahyaluronidase alfa approved for various solid tumors. While top-selling cancer drug Keytruda (pembrolizumab) was first approved in 2014, this is the first approval for an engineered variant of the hyaluronidase enzyme (berahyaluronidase alfa). Therefore, this combination counts as a novel approval.
View New Drug Approvals in 2025 with Estimated Sales (Free Excel Available)
Fondazion’s CGT okayed for Wiskott-Aldrich syndrome; three drugs approved for hereditary angioedema
Fondazione Telethon’s Waskyra (etuvetidigene autotemcel) became the first gene therapy for Wiskott-Aldrich syndrome (WAS), a rare immune disorder that causes frequent infections, bleeding issues, and eczema. The one-time treatment uses patients’ own blood stem cells that are modified to restore the faulty WAS gene.
Abeona’s Zevaskyntm (prademagene zamikeracel) became the first and only autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (a rare, genetic skin disorder).
Patients with hereditary angioedema (or HAE, a genetic disorder characterized by recurrent episodes of severe swelling) gained access to three new drugs, including two first-in-class drugs — CSL Behring’s Andembry (garadacimab) and Ionis Pharma’s Dawnzera (donidalorsen). The third drug approved to treat HAE is KalVista Pharma’s Ekterly (sebetralstat).
View New Drug Approvals in 2025 with Estimated Sales (Free Excel Available)
Our view
The FDA has been bringing about considerable changes to its processes. In June, it launched the Commissioner’s National Priority Vouchers (CNPV) program to cut review timelines from the usual 10 to 12 months to two months. But the recent rejection of Disc Medicine’s application for bitopertin as a treatment for a rare blood disorder under the program took four months to materialize. Not only did the rejection come in late, it was based on information already known to the FDA at the time of granting the coveted voucher, raising controversy around the program.
The agency is going to bring about more changes soon. It has proposed a plausible mechanism pathway for rare and ultra-rare diseases where randomized controlled trials are not feasible. And in April, it announced plans to phase out animal toxicity testing in the development of monoclonal antibody therapies and other drugs. The agency is increasingly relying on AI, and recently announced the deployment of agentic AI capabilities for all employees. It will be interesting to see how these changes impact drug approvals in 2026.
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Image Credit : NEW DRUG APPROVALS (2025 RECAP) by PharmaCompass license under CC BY 2.0
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