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Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.

Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting neurological diseases. Some failures split up partners, and one particularly egregious case even led to the demise of an entire company.

The loss of domvanalimab is the latest in a string of high-profile failures recorded across the biopharma world for the TIGIT modality, including from GSK, Merck and Roche.

Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for IgG4-related disease in April.

Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older.

The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care visits in children aged 9 months through four years, according to a new report.

Follow along as BioSpace tracks job cuts and restructuring initiatives.

With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.

In a first for the Parkinson’s field, AC Immune’s immunotherapy has stabilized key biomarkers that suggest an effect on the disease’s course.

Analysts were hoping for a safety profile similar to what was achieved in Phase II but an abnormal sense of touch, called dysesthesia, has emerged in the late-stage TRIUMPH-4 trial.

The FDA is becoming deeply compromised and increasingly at risk of being permanently transformed in ways contrary to its mission, history and culture.

While new late-stage data point to some liver toxicity signals, analysts at BMO Capital Markets said Tukysa’s efficacy outcomes “appear to more than make up for any safety concerns.”

Patent strengthens Company’s global intellectual property portfolio and reinforces the Company’s commitment to establishing and protecting competitive advantages

• Vial’s INHBE siRNA is a first‑in‑class, liver‑targeted (GalNAc‑conjugated) siRNA therapy that silences INHBE and its gene product, Activin E • Leading key opinion leaders (KOLs) Drs. Jason Fung, Scott Kahan, Lawrence Cheskin, and Lee Kaplan from leading institutions such as Johns Hopkins, GMU, and Dartmouth University respectively shared their insights on challenges with current GLP-1 treatments as well as the potential benefits of INHBE siRNA therapies like Vial’s • INHBE siRNAs are designed to deliver fat-selective weight loss while preserving lean muscle mass • Vial’s INHBE siRNA will be investigated for its potential as both a mono-therapy and in combination with GLP-1s to offer patients flexibility on their weight loss journey

Recognized for Excellence in Drug Discovery Research Services on Global R&D Sourcing Platform in 2025.