Drug Development

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The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.

Re-Vana’s drug delivery technology is designed to release treatments over a 6- to 12-month period, with the goal of reducing frequency of injections for patients.

The two companies have entered into an agreement to develop respiratory, immunology, inflammation, and cancer therapies.

The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava Aerosphere that will have a 1000-fold reduction in global warming potential compared to the current propellant.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

In this exclusive Drug Digest video, Deepak Bahl from Roquette and Jagruti Patel from Lonza look at strategies for accelerating early-stage development while reducing risk, approaches to speeding up timelines for complex formats without sacrificing quality, and maintaining a flexible CMC process that ensures quality.

Artificial intelligence and machine learning can help identify complex patterns.

The company will build a multi-billion-dollar drug manufacturing center in Virginia that will focus on chronic diseases, as well as facilities in California, Indiana, Maryland, Massachusetts, and Texas.

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.

A structured, risk-based framework for pharmaceutical compounding that enhances quality, regulatory compliance, and process consistency.

Delayed cerebral ischemia is a leading complication in the severe form of stroke known as subarachnoid hemorrhage and can result in long-term neurological damage, disability, or death.

The company estimated that more than 1000 women in Scotland at very high risk of fracture would be eligible for treatment.

Hydrogels, drug-eluting contact lenses, and other implant technologies show real promise.

Sascha Berger, private biopharmaceutical investor; Shannon Eaker, CTO of Xcellbio; Edwin Stone, CEO of Cellular Origins; and Bryce Sady, VP of Product Development at PSL Group go behind the headlines to talk CAR-T advancements, exciting M&A developments, and the impact of lost research funding on innovation.

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.

Prokaryotics will gain worldwide rights to develop, manufacture, and commercialize NAB741, a non-bioactive polymyxin designed to increase permeability of the outer membrane of Gram-negative bacteria.

The company’s mocravimod, a novel oral S1P receptor, is being evaluated for its efficacy as an addition to CAR-T cell therapies.

Cambridge Healthcare Innovations says its dry powder inhaler engine, Quattrii, can deliver large volumes of biologic and mRNA molecules in a single inhalation.

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue.

mRNA technologies offer great promise in immunotherapy and non-immunogenic applications.

A total of 13 drugs were granted recommendation for market authorization at EMA’s CHMP June 2025 meeting.