News

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

The acquisition expands tubular glass vial and ampoule capacity, expanding ready-to-use glass packaging capabilities in Europe.

Moderna’s updated Spikevax and mNEXSPIKE COVID-19 vaccines target the LP.8.1 variant of SARS-CoV-2 for high-risk groups and older adults.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, talks to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each.

Circular RNA offers enhanced stability and protein expression, making it an intriguing next-generation alternative to mRNA.

EC clears ExCellThera’s Zemcelpro, a cord blood–based stem cell therapy that offers transplant access to blood cancer patients lacking suitable donors.

Continued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, and lifecycle monitoring.

SynaptixBio CEO Dan Williams notes how rare-disease drug development is advancing on the back of FDA incentives, priority review vouchers, and a growing recognition of unmet needs.

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

In partnership with AstraZeneca, the company previously announced approval by FDA in January 2025 for the same indications.

The agreement expands researcher access to backbone modifications that boost stability and delivery of RNA therapeutics across diverse applications.

Using solid- or liquid-phase peptide synthesis or hybrid approaches, Snapdragon can now support peptide projects from development to GMP manufacturing.

VeonGen provided the first update to its lead investigational gene therapy since announcing a company rebrand in June 2025.

The decision was based on results of a Phase III trial that showed a median overall survival of 33.8 months with enfortumab vedotin plus pembrolizumab versus 15.9 with platinum-based chemotherapy.

Orlynvah is the first new, branded product for the treatment of uncomplicated UTIs to be introduced in the US in more than 25 years.

The agency has completed both pre-license and bioresearch monitoring inspections with no observations, and no safety-related concerns have been raised to date.

Ifinatamab deruxtecan shows promising trial results targeting B7-H3 in small cell lung cancer, offering a potential new option after chemotherapy failure.

Bristol Myers Squibb and SystImmune’s iza-bren shows promising efficacy and safety in EGFR-mutant NSCLC after TKI and chemotherapy, backed by data from global and China-based trials.

The company was one of 17 to receive letters from the White House on July 31 detailing the steps each company must take to bring prescription drug prices down for Americans.

There are no approved therapies for RRP that completely eliminate the need for repeated surgical procedures.

Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.

Type 1 diabetes is a lifelong condition that currently affects approximately 400,000 people in the UK.

Dan Williams, PhD, SynaptixBio CEO, discusses how rare disease drug development leverages genetic targeting and drives innovation and investment in pharmaceutical technology and precision medicine.

The Hopewell, N.J., site adds scalable, end-to-end viral vector production with integrated quality systems to speed clinical and commercial gene therapy programs.

Strand advances targeted mRNA therapies, with Phase I STX-001 solid tumor data presented at the 2025 ASCO Annual Meeting.

The company is not developing an mRNA vaccine, but had been using one as the control in a 10,000-subject Phase IIb trial.

The newly launched facility is located in The Woodlands, Texas, and will produce plasmid DNA as well as strengthen biopharma supply chains.