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UniQure does not have to drill placebo burr holes in the skulls of patients with Huntington’s disease, an unnamed FDA senior official said on Thursday. Instead, the company would anesthetize them and put “one to three nicks” in their scalp.

Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.

Financing was led by new investor and top-tier healthcare fund Nantahala Capital and longtime Envoy Medical shareholder, billionaire Glen Taylor Closing of $30 million in gross proceeds in upsized offering, with up to an additional $48 Million upon exercise of milestone warrants, provides potential funding through commercialization Company hosting Fireside Chat with Dr. Theodore McRackan, on February 25th at 10 a.m. ET, to discuss his initial experiences as clinical trial’s leading implanter

Partnership will enhance physician awareness of START’s portfolio of trials, streamline referrals, and support patient access to early-phase oncology research

Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package.

This webinar explores how collaborative-initiated trials and Investigator-Initiated Trials (IITs) are complementing traditional drug development to accelerate innovation, advance precision medicine, and address clinically meaningful questions.

The last few months have been tumultuous for the CDC, which has seen the ouster of Director Susan Monarez and all 17 members of the Advisory Committee on Immunization Practices.

Jeanne Marrazzo, former director of the National Institutes of Allergy and Infectious Disease, was formally terminated Thursday after months on administrative leave, after filing a whistleblower report.

The Phase 3 EMANATE study is a basket trial looking at the efficacy of Rhythm Pharmaceuticals’ injectable obesity drug across four types of obesities driven by specific genetic mutations.