^{Maryam Tabatabai, PharmD, is the associate vice president of clinical information at Prime Therapeutics.} 

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As 2025 draws to a close, attention turns to the drug pipeline and the regulatory landscape shaping patient access and affordability. Which therapies are positioned for potential U.S. Food and Drug Administration (FDA) approval, and what market dynamics and policy factors could influence their trajectory? 

For the past ten years, the FDA Center for Drug Evaluation and Research (CDER) has approved about 47 novel drugs each year. 2018 leads the pack with 59 novel approvals.  

Will the past be a predictor of the future?  

So far in 2025, the number of novel drug approvals sits at 35. For the remainder of this year, Prime Therapeutics (Prime) analysis estimates about 18 notable drugs filed with the agency have a potential FDA approval date in 2025. Looking back at trends in Prime’s Quarterly Drug Pipeline publication, in theory, the agency could finish the year at or around par with last year, which was 50. However, some review timelines could be extended; approvals could be denied or conversely approved earlier. Ultimately, final regulatory approvals lie with the FDA.  

Keep in mind that these numbers represent novel approvals — new drugs that contain an active ingredient not previously approved by the FDA. These numbers do not include new cell and gene therapies, supplemental approvals for new uses or formulations for existing drugs, or first-time generics or biosimilar approvals, which are covered in Prime’s Quarterly Drug Approvals publication.  

On a related note, two first-time biosimilars for the autoimmune injectable golimumab (reference product: Simponi) and the oncology injectable pertuzumab (reference product: Perjeta) are expected before the end of 2025. When taking all these buckets into consideration, Prime’s analysis suggests that the grand total of approvals will be higher.  

A closer look 

Let’s take a closer look at what’s in store. Five FDA decisions to watch for the rest of 2025 include:  

• Oral semaglutide (Wegovy). This could potentially be the first oral GLP-1 formulation that is FDA approved for obesity.  
• Etuvetidigene autotemcel. If approved, this will be the first one-time gene therapy for Wiskott-Aldrich syndrome, a rare, X-linked genetic disorder with immune deficiency and thrombocytopenia (low platelet counts).  
• Sevabertinib. This is an oral targeted agent for advanced non-small cell lung cancer with HER-2 mutation, in the second-line setting. 
• Depemokimab. This is a next-generation injectable monoclonal antibody as add-on maintenance treatment for severe eosinophilic asthma and chronic rhinosinusitis with polyps. 
• Setmelanotide. If approved, this would be the only drug to treat acquired hypothalamic obesity, a type of obesity resulting from brain injury. 

To learn more about the safety and efficacy profile of select agents as well as their clinical place in therapy, read the latest evidence-based Quarterly Drug Pipeline.  

Some common pipeline themes emerge — endocrine, oncology, cardiology, metabolic, respiratory, neurology therapeutic categories, specialty medications and drugs for rare diseases. Interestingly, over half of novel drug approvals last year were for Orphan Drugs, a disease or condition affecting fewer than 200,000 people in the United States, according to the FDA. 

New developments 

Looking beyond the drugs, several factors could impact future FDA approvals. These reflect regulatory “Priorities for a New FDA,” such as accelerating cures, including pilot programs for faster FDA decisions, leaning into artificial intelligence (AI) and reducing financial toxicity.  

1. Government shutdown 

In addition to the earlier reduction in force at the FDA and departures resulting in fewer staff, during the recent government shutdown, which started on Oct. 1, 2025, the FDA operated with an even smaller staff (86% of the staff was retained during the shutdown) and much of the agency’s important regulatory work had the potential to be delayed or paused. During government shutdowns, the FDA cannot accept new drug applications, generic drug applications, biological product applications or biosimilar biological product applications that require payment of a user fee. However, the FDA can still review applications for medical products it has already received using carryover user fee funds.

2. New voucher pilot

A new initiative introduced by the FDA Commissioner Marty Makary, M.D., MPH, the Commissioner’s National Priority Voucher (CNPV) pilot, awarded vouchers to nine companies and subsequently to another six companies, since mid-October. These recipients’ pipeline drugs are aligned with U.S. major national health priorities and are intended to enhance the health interests of Americans. According to the FDA announcement, the CNPV shortens FDA’s review times from 10–12 months to just 1–2 months following filing of a complete drug or biologic application, while maintaining FDA’s rigorous safety and efficacy standards. More on this topic can be found at Prime’s monthly Trending Topics & Drug Approvals publication. 

Three of the 15 inaugural CNPV recipients are already under FDA review.  

• Sanofi. Injectable teplizumab-mzwv (Tzield) is a disease-modifying therapy to delay progression of stage 3 type 1 diabetes in adults and pediatric patients 8 years or older recently diagnosed with stage 3 type 1 diabetes. Tzield is already approved for a certain kind of type 1 diabetes.  
• Disc Medicine. Oral bitopertin is a treatment for erythropoietic protoporphyria (EPP), including X-linked protoporphyria (XLP), rare blood diseases that lead to extremely painful and severe skin reactions with sunlight exposure. Bitopertin lowers red blood cell protoporphyrin levels.  
• Novo Nordisk. Oral semaglutide (Wegovy) is awaiting an FDA decision for obesity as well as cardiovascular risk reduction in individuals with established cardiovascular disease with obesity. Injectable Wegovy is pending approval for a new indication of heart failure in patients with obesity. 

These three drug companies — and their latest drug applications — will provide a glimpse into the FDA’s actions with this expedited pilot.  

In parallel, Sanofi and Disc Medicine’s products are seeking FDA’s Accelerated Approval, an expedited pathway for serious and life-threatening conditions, where approval is based on surrogate markers instead of efficacy outcomes. Medicines approved under this pathway require post-approval studies to confirm clinical benefit to stay on the market.  

3. Rejection letters

For the first time, the FDA is publishing complete response letters (CRLs). Also known as rejection letters in response to drug or biologic applications submitted to the FDA, these now-public documents provide transparency into the FDA’s thinking and the deficiencies identified in applications.  

4. Biosimilars

The FDA recently released new draft guidance to eliminate the need for comparative efficacy studies to approve biosimilars. The agency, through a separate initiative, plans to streamline interchangeability for biosimilars to facilitate pharmacy-level substitution of lower-cost biosimilars. This FDA solution, if finalized, has the potential to significantly speed up and increase the number of biosimilar approvals in the future and reduce red tape to expand access and affordability for patients. 

Read more about Prime’s support for the FDA’s updated biosimilar recommendations.  

5. Artificial intelligence (AI) 

A development that is expected to impact FDA approvals is AI. Earlier this year, the FDA announced successful completion of the first AI-assisted scientific review pilot. The agency also launched Elsa, a generative AI tool to modernize and increase efficiency at the FDA. This seems to be just the beginning, as the FDA plans to integrate AI into the agency functions.   

Looking ahead 

Drugs on Prime’s “Keep on Your Radar” profile contain several pipeline agents further from approval with the potential for significant clinical and financial impact, including those poised to surpass blockbuster status by 2029. Examples include drugs, gene therapy and drugs for obesity. One the gene therapy front, the FDA has signaled its interest in custom-tailored regulatory processes and flexibilities for faster review and approval of personalized gene-editing therapies that address root causes for patients with rare diseases, especially as rare conditions are a priority for this administration. 

Stay informed 

At Prime, our clinical experts continue to closely monitor the drug pipeline and approvals. Tracking approvals and pipeline provides insights into the trends — what’s new, what’s ahead and what’s impactful. Moreover, it provides a glimpse of new treatment options for patients and potential access to innovative therapies to hopefully improve health.   

How will the new FDA’s 2025 approvals stack up against years past, both in number and, more importantly, safety and efficacy? Follow Prime’s timely and credible thought leadership for more clinical insights on the drug pipeline and FDA approvals.  

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Disclaimer: All brand names are property of their respective owners. This content is for informational purposes only and does not constitute medical advice. Always consult your health care provider for guidance regarding your health and treatment options. Please note that the drug development pipeline is dynamic and subject to change. 

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