Drug Development

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The new draft guidance allows for the use of publicly available information and established platform knowledge in regulatory submissions for cell and gene therapies that use genome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

Pfizer and Innovent's $10.5B oncology collaboration spans 12 cancer programs, signaling a new model for global pharmaceutical development and cross-border drug partnerships.

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.

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.

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

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

Bristol Myers Squibb’s Hengrui agreement underscores how China-based early development may influence portfolio and manufacturing decisions.

Lilly expanded its Indiana manufacturing investment by $4.5 billion to support tirzepatide, oral glucagon-like peptide-1, and genetic medicines.

High-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers.

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

In part 2 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains what drives the need for the development of a new excipient and how involved regulators are in the process.

FDA approves AstraZeneca's Breztri as the first single-inhaler triple therapy for asthma in patients 12+, a new precedent for respiratory drug developers.

Panelists at INTERPHEX 2026 talked about the move to hybrid modeling for process development and the barriers to the adoption of artificial intelligence in pharmaceutical manufacturing.

The agency is celebrating the achievement of key first year goals in implementing the Roadmap to Reducing Animal Testing in Preclinical Safety Studies.

This week, PharmTech discussed the use of AI in real-time monitoring, a strategic collaboration in radiopharmaceutical development, and navigating regulatory hurdles.

FDA grants full approval to sparsentan for FSGS, the first-ever treatment for the rare kidney disease, backed by Phase III data showing 48% proteinuria reduction.

In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a new excipient.

CPHI Americas 2026 tackles pharma's pressing challenges such as: regulatory shifts, AI in drug discovery, biologics innovation, and supply chain resilience.