As 2026 unfolds, oncology continues to dominate the US drug approval pipeline by volume. PDUFA timelines act as a structural driver of activity across pharmaceuticals and biotechnology, with assets under FDA review moving through defined regulatory milestones that shape how organizations plan, sequence, and resource their programs. 

Where 2026 approval volume is concentrated 

Oncology will account for roughly one third of all PDUFA actions in 2026. Neurology and metabolic disease follow, with a strong concentration of first-in-class and platform-driven assets. 

Estimated PDUFA share by therapeutic area in 2026 

• Oncology, around 32%  - ADCs, bispecific antibodies, and oral SERDs remain the dominant modalities. 

• Neurology, around 22% - Activity centers on multiple sclerosis, orexin-based sleep disorders, and Parkinson’s disease. 

• Metabolic and Obesity, around 18% - Oral GLP-1s and PCSK9 inhibitors lead late-stage development. 

• Rare and Orphan disease, around 15% - Gene therapies for pediatric lysosomal disorders continue to progress through review. 

• Other areas, around 13% - Immunology, mRNA vaccine programs, and ophthalmology. 

Industry data consistently shows oncology as the most active development area globally, both in pipeline size and capital allocation.  

How timing in 2026 is shaping hiring decisions 

The spread of PDUFA dates across the year is uneven, which has a direct impact on hiring behavior. 

• Q1 2026 is heavily weighted toward gene therapies and oncology resubmissions. These programs demand regulatory, quality, and clinical leaders in place early due to frequent FDA interaction, inspection readiness, and limited tolerance for execution gaps during review. 
• Q2 2026 is concentrated in cell therapy and rare disease. Manufacturing readiness, CMC, and clinical operations hiring accelerates well ahead of regulatory outcomes as programs manage complex supply chains, validation requirements, and heightened FDA oversight for advanced therapies. 
• Q3 and Q4 2026 include several late-year decisions with direct commercial impact. Market access, medical affairs, and commercial leadership hiring peaks earlier than many organizations anticipate, driven by payer strategy development, launch sequencing, and external scientific engagement. 

Companies to watch in the 2026 PDUFA cycle

Several publicly traded and private biopharmaceutical companies stand out in 2026 due to the timing, complexity, and potential impact of their regulatory milestones. These programs span oncology, rare disease, and advanced therapies, and they are already influencing hiring activity across the market. 

• Regenxbio has a late-stage gene therapy pipeline advancing toward potential regulatory action, including pivotal trials for metabolic and neuromuscular disease candidates such as RGX-202 for Duchenne muscular dystrophy and related programs; its platform also includes candidates in retinal disease that may generate regulatory engagements in 2026.  
• Rhythm Pharmaceuticals is developing precision medicines for rare genetic obesity and related neuroendocrine diseases, with ongoing clinical progress that keeps regulatory and commercial timelines under focus in 2026.  
• Aldeyra Therapeutics continues to pursue regulatory clarity on key clinical assets, including reproxalap for ocular and immune-mediated disease indications. Its ongoing review history makes it relevant for hiring plans tied to regulatory resolution and potential next steps.  
• Vanda Pharmaceuticals is advancing regulatory decisions on late-stage gastrointestinal and neuropsychiatric programs, including tradipitant, which is in active discussion with the FDA and set for a decision later in the cycle. 
• AstraZeneca (with partners such as Daiichi Sankyo) continues to progress large-scale oncology programs that are prominent in 2026 regulatory and commercial planning due to scale, modality diversity, and competitive implications.  

These companies reflect a mix of modalities, from gene therapy to rare disease precision medicines to large oncology portfolios, and hiring pressure often precedes regulatory milestones as teams prepare for submission review, inspection readiness, and launch sequencing. 

As Sean Power, Senior Vice President at EPM Scientific, explains:

Pharmaceuticals and biotechnology building teams before approval 

Across pharmaceutical and biotechnology companies, waiting for approval to hire is no longer workable. Late-stage programs under review in 2026 are triggering earlier and more deliberate hiring cycles. 

Common pre-approval hires include: 

• Senior clinical development and medical directors 
• Regulatory affairs leaders with FDA submission experience 
• Quality and pharmacovigilance professionals 
• CMC and manufacturing readiness specialists 

Mid-sized biotech companies feel this pressure most sharply. They compete directly with large pharma for a limited pool of specialists, particularly in oncology, neurology, and rare disease. As Sean explains:

Research and development under late-stage pressure 

R&D teams supporting 2026 launches operate under sustained regulatory scrutiny. In oncology and gene therapy programs, late-stage development leaves little room for interpretation or rework. Data quality, endpoint selection, and consistency across submissions now sit directly in the FDA’s line of sight, with clear consequences for approval timing and label scope. 

For many programs, especially first-in-class or rare disease assets, regulators expect a well-supported scientific narrative that connects mechanism of action, clinical endpoints, and real-world relevance. This places pressure on R&D functions to move beyond data generation and toward data defense. Teams must anticipate questions, justify decisions, and respond quickly during review cycles. 

As a result, R&D hiring has shifted away from early discovery scale and toward late-stage execution strength. Companies are prioritizing: 

• Biostatistics and data science leaders with hands-on experience supporting NDA and BLA submissions, including complex endpoint modeling and sensitivity analyses 
• Translational scientists who can bridge preclinical rationale with clinical outcomes and support regulator-facing documentation and advisory committee preparation 
• Clinical operations professionals with direct experience managing inspections, audits, and protocol compliance under FDA review 

In 2026, R&D hiring aligns more closely with regulatory milestones than with pipeline expansion. Organizations are building teams based on submission readiness, inspection risk, and review intensity rather than long-term portfolio growth. This reflects a broader shift toward execution-focused R&D, where approval outcomes depend as much on team capability as on the underlying science. 

Regulatory, quality, and compliance as execution functions 

As assets move through approval, regulatory, quality, and compliance teams shift fully into execution. In rare disease, cell therapy, and first-in-class oncology programs, limited precedent raises expectations around documentation quality and FDA engagement. 

Experienced regulatory and quality professionals provide continuity from submission through approval and into postmarketing obligations. 

Commercial, market access, and medical affairs before approval 

Commercial preparation for 2026 launches starts well before FDA decisions, particularly in oncology and high-cost rare disease indications. Market access strategy, HEOR evidence, and scientific engagement planning are already underway for many assets. 

 Industry outlooks continue to stress the need for early commercial alignment, as payer scrutiny increases, including views from the Deloitte life sciences outlook. 

The talent patterns shaping 2026 programs 

Across organizations operating in late-stage development, EPM Scientific is seeing consistent talent patterns tied directly to execution risk. Hiring decisions are shaped by submission readiness, inspection exposure, and the need for continuity through FDA review. 

Clients are prioritizing candidates with direct late-stage or FDA approval experience across oncology, neurology, rare disease, and advanced therapy programs. Individuals who have supported submissions, managed inspections, and led regulator engagement are favored over broad functional generalists. 

Hiring timelines have moved earlier, with roles secured in parallel with regulatory submissions. To manage peak workload around submissions, inspections, and launch preparation, many organizations rely on interim and contract professionals, particularly in regulatory affairs, clinical operations, quality, and CMC. 

At the same time, appetite for generalist profiles has declined in high-risk programs. For 2026-focused assets, depth of experience and proven delivery outweigh role breadth. 

What this means for hiring managers  

For hiring managers, 2026 highlights the cost of reactive hiring. Delayed decisions reduce candidate choice, increase competition for specialist talent, and raise delivery risk during critical regulatory phases. Many of the most qualified candidates are engaged early through targeted searches tied to regulatory milestones. Hiring managers planning for submissions, inspections, or commercialization in 2026 benefit from early visibility into talent availability and market conditions.  

If you are hiring in life sciences and supporting a 2026 approval timeline, you can request a call back from EPM Scientific to discuss current hiring pressure points, realistic timelines, and access to specialist talent before demand peaks.  

What this means for professionals  

For professionals, experience linked to late-stage development and FDA approvals continues to carry long-term value.  

Many 2026-focused roles are not widely advertised as companies often move confidentially or engage search partners early. Registering your CV to EPM Scientific provides access to opportunities that are not yet public and aligned to your experience.