Drug Development

Four FDA approvals in the areas of HIV, diabetes, autoimmune disease, and COVID-19 vaccines came in a flurry in late August 2026.

As the biologic pipeline diversifies across ADCs, bispecific antibodies, and fusion proteins, formulation science has become the critical discipline bridging molecular complexity and patient-ready therapy.

FDA approves Rasonque (daraxonrasib), the first broad RAS-targeted therapy for metastatic pancreatic cancer, validating RAS(ON) inhibition for future drug development.

Centrix and University of Sussex launch a data analytics partnership to reduce development risk, rework and delays in early-stage pharma programs.

Continuous direct compression can provide a simplified alternative pathway for selected spray-dried dispersion formulations when supported by a material-property-driven development strategy.

European biotechs are advancing bioinks and high-resolution bioprinting for medical devices and regenerative tissues.

FDA priority review of Jemperli for biomarker-defined rectal cancer signals capacity, supply chain, and global filing shifts for manufacturers.

McKesson will acquire Precision Medicine Group for $2.25B, integrating clinical research and commercialization services within its oncology segment.

REGENXBIO's RGX-121 faces an FDA clinical hold after asymptomatic spine MRI findings, highlighting long-term imaging surveillance for CNS gene therapies.

The FDA grants accelerated approval to Ultragenyx's Genglycos, the first gene therapy for GSDIa, raising manufacturing and post-market monitoring questions.

The FDA approves first therapy shown to reduce new bone lesions and flare-ups in fibrodysplasia ossificans progressiva (FOP), based on a 63-patient trial using CT-scan efficacy endpoints.

The Trump administration nominates Heidi Overton for FDA commissioner amid leadership instability, raising questions for drug developers on review timelines and oversight.

FDA grants Priority Review to Teva's ecopipam new drug application, backed by phase 3 data. Ecopipam is a first-in-class D1 receptor therapy for pediatric Tourette syndrome.

The collaboration will use Andelyn’s viral vector process to produce clinical-grade material for an upcoming gene therapy trial.

LEO Pharma acquires dersimelagon from Tanabe Pharma for up to $435M, adding a late-stage oral rare dermatology asset under FDA review.

A dual-delivery capsule platform delivers multiple APIs in a single dosage unit, reducing pill burden and simplifying dosing regimens.

FDA approves TAUKLARIFY, a tau PET imaging agent for Alzheimer's, adding a biomarker tool that could shape trial design for drug developers.

Richard Jaenisch, Open Biopharma breaks down AI's real limits in drug discovery, agent security risks, and what workforce readiness looks like by 2028.

Sentynl and Mereo's alvelestat deal for AATD-LD signals early manufacturing collaboration ahead of phase 3, shifting care from IV to oral therapy.

This year’s conference agenda includes more than 260 industry experts, a new Sustainability Summit, and zones targeting AI, cold chain, and labeling.

BMS's Investing $2.3B into its Houston campus signals a shift toward flexible, multi-modal manufacturing.

Venture-based Danish biotechs are driving innovation and gaining traction with investors.

The genetically modified oncolytic viral therapy, used in combination with nivolumab, was approved by the agency after data showed 1 in 4 patients responded to treatment.

The FDA approved the first orexin receptor agonist for narcolepsy type 1, which validates a new mechanism-driven approach shaping CNS drug development and regulatory pathways.

Pathos AI's $2.09 billion license for Alphamab's TNBC drug JSKN016 signals rising cross-border oncology deals and manufacturing coordination demands.