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.

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.

Kristin Ciriello Pothier, KPMG US, discusses deal discipline, manufacturing diligence, and why oncology and GLP-1s are driving biopharma M&A activity in 2026.

MilliporeSigma's Sebastián Arana explains why modular, digital, platform-based manufacturing, not raw capacity, will define biomanufacturing's next decade.

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.

The future of synthetic biology will depend not only on the ability to design biological systems, but on the capacity to manufacture DNA reliably at scale within regulated frameworks.

The agency approved palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer.

How the Lehigh Valley Economic Development Corporation is building a technical workforce pipeline to support Eli Lilly's 850-job pharmaceutical manufacturing expansion.

The aim of this study was to develop and optimize an orally dissolving film formulation containing a blend of active ingredients in a strategic combination of natural and synthetic excipients to achieve a balance between controlled actives release and rapid onset of action.

The FDA's revised draft guidance updates master protocol recommendations on randomization, control groups, blinding, and regulatory submissions for multi-drug trials.

Merck is collaborating with Versant Ventures to establish a portfolio of treatments for rare genetic cardiomyopathies. The company also announced the winners of its 2026 Future Insight Prize and its 2026 North American Advance Biotech Grant.

The scientific basis, regulatory expectations, validation approaches of hold times in biopharmaceuticals are presented along with real-world examples.

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

AbbVie acquires Apogee Therapeutics for $10.9 billion, gaining zumilokibart, a long-acting injectable targeting atopic dermatitis and asthma with once-quarterly dosing potential.

PharmTech Europe's June 2026 issue reflects the convergence of compliance burden, cost pressure, analytical complexity, and patient access.

Kristin Ciriello Pothier, KPMG US, discusses why pharma dealmaking slowed in early 2026, but how AI partnerships, manufacturing acquisitions, and oncology are driving a second-half rebound.