Industry News

Bristol Myers Squibb is seeking approval of Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory marginal zone lymphoma, making this the fifth cancer type for which the cell therapy would be approved.

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

The investment is part of CGT Catapult’s Cross-Catapult Investment Pilot and will accelerate the pre-clinical development of Spliceor’s trans-splicing gene therapy platform.

Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.

Scientists at MIT and other institutions have discovered compounds that activate a defense pathway inside host cells that could be used as antiviral drugs.

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

The consortium will focus on the delivery of a fully automated robotics cell and gene therapy manufacturing platform.

EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond.

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

BioPharm International® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the impact geopolitical changes in Europe might have on the bio/pharmaceutical industry.

Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.

The agency has approved BMS’ Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

The company gave a first look at its completed expansion at its manufacturing site in Gliwice, Poland during DCAT Week 2025 in New York City.

BioPharm International® spoke with Alison Moore, chief technical officer, Codexis to find out the latest about the RNA therapy market and to get perspective on how enzymatic RNA synthesis is used to synthesize RNA molecules.

BioPharm International® chats with Simon Wright from Almac Pharma Services about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.

The Member Company Announcement Forum is the kickoff event of the annual DCAT Week in New York City, which is being held from March 17–20.

PharmTech Group spoke with Peter Belden, president of Tjoapack US, ahead of DCAT Week 2025 to discuss recent innovations in bio/pharmaceutical packaging.

In an interview with BioPharm International®, Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.

Gender diversity and equality in leadership positions have been shown to improve profitability and return on equity through greater innovation and more creative solutions.

In an interview with BioPharm International®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

The partnership will advance the accessibility, scalability, and affordability of RNA-based vaccines.

EMA’s CHMP recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

FDA has accepted Sanofi’s sBLA for the mAb and granted it priority review status for the targeted treatment of bullous pemphigoid.

The new AI co-scientist is a multi-agent AI system that acts as a virtual scientific collaborator to aid scientific research.