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Eli Lilly offers weight loss drug Zepbound directly to consumers while Novo Nordisk continues to struggle with supply challenges for its own GLP-1s. Meanwhile, gene therapies for retinal diseases target competitive market, and layoffs persist.

The intellectual property landscape for newer gene-editing technologies, like that for CRISPR-Cas9, remains unclear and hard to navigate.

Analysts expect the companies’ Vabysmo and Eylea HD to generate a combined $13.2 billion by 2030 in the vascular endothelial growth A therapy market, as healthcare providers and patients switch from older products.

Astellas Gene Therapies is closing its San Francisco biomanufacturing facility, shifting gene therapy manufacturing to North Carolina, cutting at least 17 employees and affecting dozens more.

Bayer’s Kerendia, at the center of a $3 billion sales forecast, reduced the risk of cardiovascular death and heart failure in a Phase III trial.

The highly anticipated results come as the company makes significant changes to its C-suite. Despite the turnover, Dyne said it is looking toward expedited approval pathways for its DMD treatment.

The BTK inhibitor showed promise in non-relapsing secondary progressive multiple sclerosis but not relapsing MS. The company said it plans to apply for approval for the former “as soon as possible.”

Novo Nordisk’s continuing supply problems for semaglutide come as the pharma tries to expand the drug’s indication, opening it up to more patients—and potentially to heavier production pressures.

Unlike Pfizer/BioNTech and Moderna, Novavax does not use mRNA technology for its COVID-19 vaccine, instead opting for a recombinant version of the virus’ spike protein to elicit protection.

With promising early results, cell and gene therapies are making headway against both rare and common ocular and auditory diseases.

The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.

With gene therapies by REGENXBIO and AbbVie, Adverum and others in mid- or late-stage trials, this therapeutic class could soon be an option for this common cause of blindness in the elderly.

66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046) FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 Meeting Company responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and Biologics Licensing Application via Accelerated Approval Program Company’s NYSE American listing included in the Russell Microcap, Russell Microcap Value and Russell Microcap Growth indexes

MHRA seeks to harmonize UK & US regulatory review via Project Orbis EMA Rapporteur Scientific Advice Meeting scheduled for October 2025

Investment accelerates Maxwell’s path toward FDA trials and global market readiness