Couple interesting meetings for FDA Commissioner Makary: met with Arnold Ventures on Mar. 3 about "collaboration opportunities" fda.gov/news-events/pu… and with $MNPR on "establishing a regulatory mechanism" on Mar. 13 fda.gov/news-events/pu…

Today, U.S. FDA issued final guidance on collecting and submitting patient preference information, strengthening the agency’s commitment to patient engagement and advancing safe, effective medical devices. fda.gov/regulatory-inf…

There’s a fair point that whoever steps into the CBER Director role will be stepping into a challenging role. What I don’t agree with is the idea that the uniQure AMT-130 data were not evaluated on their merits. There was a scientific argument made based on the RCT and follow up

Insilico Medicine Announces Global R&D Collaboration with Lilly insilico.com/news/uiy12zcjg…

New: Trump's surgeon general pick, Casey Means, has tried for over a month to secure meetings with the two GOP senators who could sink her nomination. She's so far been unsuccessful—another ominous sign for her candidacy amid a brutal few months for HHS' priorites w Sarah Owermohle

The new FDA is delivering more efficient drug reviews for the American people.

Exclusive: Vaccine makers Pfizer and BioNTech halted recruitment for a large US trial of their updated COVID-19 vaccine in healthy adults aged 50 to 64, saying enrollment in the trials had been too low to generate the needed data reut.rs/4m4S5zZ

Today, there’s a new option. Learn more about the impact a little pill could make. e.lilly/4s1cPtP

What could possibly go wrong? #CDC pauses support for states on testing for #rabies & #mpox because it doesn't have the personnel to do the work. 2 pathogens you really don't want to mess with, rabies & mpox. nytimes.com/2026/04/01/hea…

The American people deserve an FDA that is responsive and efficient. Five drugs have been approved so far under the national priority voucher pilot program, which helps the agency move efficiently on applications that advance Americans’ key interests.

Recapping a year's worth of progress, taking a moment to recognize our amazing staff, and discussing what's next for U.S. FDA.

New study has strengthened link between infectious mono and Multiple Sclerosis. By analyzing 2 decades of health records, researchers found people who contracted mono as teenagers or adults were 3x more likely to develop MS later vs those who didn’t neurology.org/doi/10.1212/WN…

The FDA has reminded over 2,200 medical product companies and researchers of their legal requirement to submit clinical trial results to ClinicalTrials.gov. Currently, 29.6% of required trial results are missing from the database. Transparency in research is essential to

Today, the FDA issued a draft guidance that when finalized, will provide recommendations for standardized methods for sponsors developing human gene therapy products that incorporate genome editing technologies. fda.gov/news-events/pr…

Negative trial results often go unreported by companies and researchers, leaving significant gaps in the public record. Reporting results is not optional—it’s a legal and ethical obligation that helps protect patients and strengthen scientific integrity. fda.gov/news-events/pr…

SCOOP: A report showing the effectiveness of the covid-19 vaccine that was previously delayed by the head of the CDC has now been blocked from being published in the agency’s flagship scientific journal, per sources. My latest. washingtonpost.com/health/2026/04…

New: Covid-19 vaccines roughly halved the chances a US adult would need to visit the ER or be hospitalized with their infections last fall and winter, according to two sources familiar with the findings of a new study. But you won’t hear about it from the agency that led the

Today we’re introducing two big steps for health at OpenAI: - ChatGPT for Clinicians, a free version of ChatGPT designed for clinical work - HealthBench Professional, a new benchmark to evaluate real clinician chat tasks We’re excited about what this can unlock for care. ❤️

Today, the FDA along with @CMSGOV announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway. This collaborative initiative aims to accelerate Medicare coverage for select FDA-designated Class II and Class III medical devices. fda.gov/news-events/pr…

$REGN wins FDA approval for its gene therapy to treat a very rare genetic form of hearing loss. The company is giving away the therapy for free. OTOF-related hearing loss affects approx. 50 newborns per year, so really rare, but... are there any concerns from other gene therapy