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2026 First-Half FDA Novel Drug Approvals: Modality Trends and Chemistry Supply Signals
FDA novel drug approvals are usually discussed from a therapeutic or regulatory perspective. For discovery, CMC and supply-chain teams, the same list also serves as a practical signal: it shows which molecular formats are advancing into real-world development, which types of materials become harder to source, and where chemistry capabilities need to keep pace. By the end of June 2026, the FDA's 2026 novel drug approvals listing included 23 entries. Small molecules remained the largest part of the mix, but the first half of the year also highlighted a broader technical landscape: peptides, fusion proteins, monoclonal antibodies, antibody-drug conjugates, targeted protein degraders and other complex modalities.
RAS Inhibitors as Payloads: ADC vs DAC and the Linker Chemistry Behind Targeted Delivery
RAS has become one of the most important stories in targeted oncology. For decades, RAS proteins were described as "undruggable" because they bind GTP and GDP with high affinity, lack obvious deep binding pockets and sit at the center of multiple growth-factor signaling networks. That view has changed. Structure-guided discovery, covalent chemistry, non-covalent inhibitor design and new concepts such as RAS(ON) multi-selective inhibition have opened a field that once looked closed.
Oligonucleotide Therapeutics Market Trends: Modalities, Delivery Platforms and Supply Chain Opportunities
Oligonucleotide therapeutics have moved from a specialist field into a central part of modern drug discovery. The reason is straightforward: they give drug developers a direct way to modulate genetic information. Instead of looking for a small molecule binding pocket or engineering a large protein-based therapeutic, oligonucleotide drugs can be designed against an RNA sequence, a splice site, a disease-causing transcript or, in some cases, an RNA structure. That design logic has made the field attractive for diseases that were once considered difficult to address with conventional modalities.
Chemical Modifications and Solid-Phase Synthesis of Oligonucleotide Therapeutics
Oligonucleotide therapeutics such as antisense oligonucleotides (ASOs) and small interfering RNA (siRNA) are built around a simple biological idea: short nucleic acid sequences can recognize RNA targets through base pairing and modulate gene expression. That idea is powerful, but natural nucleic acids are not automatically drug-like molecules.
Scale-Up Challenges in Oligonucleotide and LNP-Related Manufacturing
Scale-up is not simply a matter of making the same process larger. In oligonucleotide synthesis, purification and LNP formulation, process behavior can change when equipment size, batch volume, flow path, mixing time or heat and mass transfer changes. A condition that works in a small research batch may not produce the same impurity profile or physical quality at larger scale. For companies developing siRNA-related programs, scale-up risk should be considered early. Route choices, reagent quality, purification strategy, analytical methods and delivery platform all influence whether a process can move from milligram or gram quantities to larger development batches.
Critical Quality Attributes for Oligonucleotide Intermediates
Critical quality attributes, or CQAs, are physical, chemical, biological or microbiological properties that should be controlled to ensure a material is suitable for its intended use. For oligonucleotide intermediates and related materials, CQAs are closely tied to identity, purity, impurity profile, stability and downstream performance. Oligonucleotide quality control is more complex than a single purity number. The molecule is sequence-defined, charged, often modified and sometimes conjugated to a ligand. A material may require confirmation of molecular weight, sequence, modification pattern, water content, counterions, residual solvents and related impurities.