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The organization’s set of product-specific biologics emerging standards are available on its Emerging Standards Platform for public comment.

FDA instability, staff turnover, and evolving review standards are reshaping drug development. Richard Pazdur, formerly with the FDA, shares what sponsors need to know now.

The new draft guidance allows for the use of publicly available information and established platform knowledge in regulatory submissions for cell and gene therapies that use genome editing in human somatic cells.

Erez Israeli, chief executive officer of Dr. Reddy's Laboratories, provides insight on the company’s generic version of semaglutide, which entered the Canadian market in May 2026.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains how important infrastructure is for radiopharmaceutical development.

FDA approves inhaled insulin Afrezza for children aged 6+, expanding pediatric diabetes care and highlighting inhaled biologics' manufacturing complexity.

This week's news and expert commentary shows that regulatory timelines are tightening, strategic capital is moving into new therapeutic categories, and long-standing operational gaps are demanding real solutions.

PharmTech takes a look back at US and European regulatory news from the month of May 2026.

Dr. Christine Allen, Co-Founder and CEO of Intrepid Labs, and Dr. Andrew Lewis, Chief Scientific Officer of Quotient Sciences, explain how AI can be used in drug development to shorten development timelines.

FDA extends AstraZeneca’s camizestrant's review deadline to assess additional data after its advisory committee failed to reach a majority vote in April.

The cell and gene therapy manufacturing workforce is having to expand on deliverables while remaining under trained.

Sandra Coufal, Toragen, discusses her team's research targeting precancerous cervical cells, backed by a Gates Foundation grant and world-class advisors.

The CMA will improve Europe’s manufacturing resilience and lead to greater diversification and reduced reliance on single external suppliers.

Lilly acquires three biotech firms for up to $3.83 billion, targeting vaccines that may prevent not just infection but also downstream neurological and oncological disease.

Pharmaceutical serialization must evolve from regulatory compliance into operational intelligence, addressing hidden failures like exception overload, certificate expiry, and 3PL complexity.

Sandra Coufal, Toragen, shares promising Phase I results showing dramatic HPV DNA reductions and tumor shrinkage, with Phase II set to confirm efficacy and safety.

Increased regulatory flexibility for rare diseases, a critical shift toward automated, data-driven manufacturing, and strategic acquisitions in genetic medicine were some of the highlights this week.

European biotechnology companies are increasing patient access to innovative cell and gene therapies through decentralized next-generation manufacturing platforms.

Quantum chemistry is accelerating drug discovery AI by providing physics-based, reproducible, and scalable data that encodes molecular reality.

Bristol Myers Squibb collaborates with Anthropic to accelerate drug development, manufacturing quality systems, and regulatory documentation via AI integration.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure.

Sandra Coufal, MD, Toragen, discusses advancing TGNS15 with strong IP, liquid formulation, and an accelerated FDA pathway, potentially saving millions on IND-enabling studies.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients.

Lilly’s Engage Bio acquisition adds a preclinical non-viral DNA delivery platform to its genetic medicines development portfolio.

Stuart Tindal, Sartorius, and David Chau, Thermo Fisher, discuss automation, single-use technology limits, and predictive control shaping continuous bioprocessing's future.

Sandra Coufal, MD, Toragen, discusses how TGN-S15's preferred enantiomer showed no neurotoxicity and reduced tumor growth, supporting development of the oral cancer drug.

Deborah Smook, co-founder and co-owner of TurboFil Packaging Machines, explains some of the challenges involved with prefilled syringe manufacturing.

Building resilient, adaptable operations capable of evolving alongside the rapid transformation of the biologics industry is key for downstream processing.

The FDA replaced acting heads of its drug and biologics centers, deepening leadership instability that raises concerns for pharmaceutical developers.

2026 regulatory shifts are accelerating rare disease drug approvals and reshaping clinical development, evidentiary standards, and pharmaceutical manufacturing strategies.