FDA approves subcutaneous isatuximab-irfc for multiple myeloma, backed by trial data showing efficacy comparable to IV dosing across three regimens.

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.

Three regulatory actions are coming together in an effort to move biologics, the gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, Parexel.

Ocrelizumab biosimilar for multiple sclerosis: Teva and Polpharma Biologics sign global deal covering intravenous and subcutaneous forms.

PharmTech spoke with Jamie Evans, manager of analytical method development and validation, and Joe Cobb, CPIP, manager of formulations, both with Lonza Capsugel, about best practices for pharmaceutical technology transfer.

To drive long-term success, CROs need to strengthen their focus on efficiency, automation, data integrity, and compliance to generate higher ROI for clients.

It is essential to understand how raw material variability can create challenges in process control for autologous adoptive cell therapies.

Advances in personalized medicine, biopharma, and digital technologies are unlocking treatments for complex and rare conditions.

FDA approves a new IgA nephropathy therapy that targets two immune cytokines at once, offering a weekly, self-administered treatment option.

PharmTech spoke with Gabriela Grasa Mannino, Senior Director, Advanced Supply Chain Solutions, US Pharmacopeia about the current state of the drug supply chain and what actions USP is taking to make supply more secure.

In a string of ADC acquisitions, Novartis agreed to acquire Myricx Bio for up to $1.5 billion, gaining an NMTi ADC payload platform designed to overcome resistance in solid tumor treatment.

An FDA warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting can support documentation work only when the resulting document is subject to quality-system controls.

FDA's 12-digit NDC rule demands industry-wide barcode, labeling, and data system overhauls, manufacturers must act now to avoid pharma's Y2K moment.

June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.

BioPhorum launches a 20-member collaboration uniting pharma, CDMOs, and regulators to address manufacturing challenges in small molecule drug production.

FDA has approved Tregzi, the first regulatory T-cell therapy shown to reduce chronic GVHD and improve survival in blood cancer transplant patients.

The company’s thyroid eye disease treatment will be the first at-home subcutaneous disease-modifying treatment if approved.

This episode of Ask the Expert takes a look at recent regulatory actions impacting biologics manufacturers.

The FDA again rejected Unicycive's oxylanthanum carbonate over third-party manufacturing compliance, not safety, spotlighting CMC risk in nanoparticle drug development.

The outsourcing company is adding commercial-scale capabilities to manufacture HPAPI and ADC payload-linkers.

The companies have been selected to participate in the pilot program to expand domestic pharmaceutical manufacturing and strengthen the US drug supply chain.

Documentation reliability across CDMOs, CROs, and other contractors should be engineered into quality systems before, during, and after execution, not patched together at submission or inspection time.

This week, the industrialization of advanced biologics, sustained regulatory and investment momentum behind next-generation therapeutics, and an ongoing push across the supply chain to improve standardization and efficiency were themes covered on PharmTech.

AI is reshaping GMP documentation and quality workflows, but human accountability remains non-negotiable, and the regulatory consequences for over-relying on AI are real.

MilliporeSigma's Sebastián Arana breaks down CGT manufacturing's biggest scale-up gaps and why supply chain collaboration is now essential.

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships play a role.

At BIO 2026, Thermo Fisher's Anil Kane explains how AI is reshaping CDMO workflows and what biotechs should prioritize when choosing a development partner.

What pharma’s regulatory writers can borrow from clinical AI before the next inspection.