With fresh billions unlocked in the 2026 U.S. budget and mission‑driven family offices recalibrating after a “nuclear winter,” early stage biotechs are rewriting their financing strategies around ...

Employees are reassessing, leaders are celebrating data that should make them nervous and job seekers are absorbing a ...

Merck’s Keytruda will soon lose exclusivity, just as weight-loss giants Eli Lilly and Novo Nordisk press in with their blockbuster GLP-1s.

UniQure and REGENXBIO are both dealing with FDA setbacks for their respective gene therapies, as regulatory experts question the FDA’s decision-making processes; CBER director Vinay Prasad is under ...

The settlement, which requires Moderna to pay the plaintiffs $950 million upfront plus up to $1.3 billion in contingent commitments, is an outcome “better than feared,” according to analysts.

Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche ...

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications.

In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome gene therapy should provide evidence of normalized or improved biomarker ...

Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with CNBC, the agency confirmed ...

Poplar Therapeutics is seeking a “step change” in the treatment of food allergy and other atopic conditions, with $95 million ...

A combination of Merck’s Keytruda and Pfizer’s Padcev could offer a chemotherapy-free treatment alternative for patients with ...

The FDA last October paused Intellia Therapeutics’ late-stage CRISPR studies after detecting life-threatening enzyme elevations in one patient, who died a few days later.