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.

In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopeias.

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

Postmarketing governance must be evidenced across the full life cycle—design, validation, and live monitoring—not documented once and assumed to hold.

Samantha Hadfield, PPD, explains how mixed FSP/FSO models help sponsors balance speed, cost, and complexity in clinical trial outsourcing.

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.

This episode of PharmTech Explained discusses how China's biotech surge is reshaping US drug licensing, manufacturing control, and FDA data trust, the key shifts pharma professionals must track.

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

Glenn Herring, Halo Pharma, discusses its new sterile fill-finish platform: Groninger/SKAN tech, GMP design, and 2026 qualification timeline.

In part 2 of this 2-part interview, Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, tells PharmTech about the challenges in achieving sustainability in pharma and how the CPHI Sustainability Summit, which launches at CPHI Milan 2026, can help organizations tackle these challenges.

This week, a $2.3 billion manufacturing campus and a new fill-finish platform signal capacity is crucial; AI in pharma is still evolving; and CPHI Milan previews a new Sustainability Summit.

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

Lee Karras, CEO, Halo discusses the company's new sterile fill-finish platform, Apotex partnership, and injectable onshoring strategy.

EMA’s draft GMP Annex 22 sidelines LLMs in critical manufacturing, fueling a push for risk-based guardrails and human accountability.

PharmTech spoke with Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, about the new Sustainability Summit that will launch at CPHI Milan 2026 and how it can help organizations obtain measurable, commercially viable solutions for sustainability in the pharma industry.

Pen injector pre-assembly demands 160 PPM precision: LVDT/vision systems, tolerance control, and GAMP5 challenge testing ensure ISO 11608 compliance.

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.

Glenn Herring, Halo Pharma, details the CDMO's new sterile fill-finish platform, Groninger/SKAN tech, GMP/Annex 1 design, and 2026 qualification timeline.

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

Lee Karras CEO, Halo Pharma ties the move to US injectable capacity along with an introduction to Halo’s new sterile fill-finish platform before GMP qualification.