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Ironic, given that U.S. FDA Commissioner Martin Makary and #CBER Director Vinay Prasad announced their new framework for COVID vaccine approvals in an NEJM editorial last week

NEW: CDC, which makes vaccine recs, is blindsided as RFK Jr. changes covid-19 vax recs for kids + pregnant women. CDC found out “when it was tweeted,” one federal official said. Five hours later, HHS sent a directive that added to confusion. My story. washingtonpost.com/health/2025/05…

“Formatting issues”

BUDGET: White House releases full Appendix for agency budget proposals to allow appropriations process to start whitehouse.gov/wp-content/upl…

Pfizer CEO: HHS claims of ‘concealed safety concerns’ on mRNA vaccines are ‘completely inaccurate’ cnn.com/2025/05/30/hea…

And now for that #ACIP recommendation …

"Resource constraints" - U.S. FDA Commissioner Martin Makary has repeatedly said the proverbial trains are running on time at the agency despite the personnel losses. Evidence suggests otherwise.

Senate HELP schedules hearing for cdc director nominee Monarez on day 1 of what should be a very unique ACIP…

June ACIP agenda up. cdc.gov/acip/downloads… #vaccines

Cassidy is calling to delay the ACIP meeting.

And we're underway at ACIP - member roster finally posted, 7 voting members total, 1 less than RFK initially annoucned. Michael Ross not listed as a member.

#ACIP will create new workgroups to look at cumulative childhood vaccine and adolescent vaccine schedules and vaccines that have not been subject to review in several years, such as hep B at birth

Best I can tell, these letters are already public as part of drug approval packages previously posted by FDA. So, maybe not such a BFD...

FTC takes action against telemedicine firm NextMed over charges it used misleading prices, fake reviews, and deceptive weight loss claims to sell GLP-1 weight-loss programs: bit.ly/3IJdjDV /1

At $GSK Blenrep ODAC, U.S. FDA designated federal officer reads new statement advising industry rep not to engage in "unseemly advocacy," mentions non-voting status at least half dozen times

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much insights.citeline.com//pink-sheet/pr…

Today I'm thinking about this: when Hurricane Helene devastated Appalachia last year, my public radio colleagues in North Carolina, West Virginia, and Southwest Virginia stepped up. They broadcast the emergency alerts. They carried the official press conferences live.

$SRPT The FDA asked Sarepta to stop shipping Elevidys and the company refused. It’s hard to see what is gained by digging in their heals here. FDA also revoked the platform technology approval for the LGMD gene therapies. fda.gov/news-events/pr…

The media is not equating Elevidys in DMD with SRP-9004 for LGMD as $SRPT suggests. We all realize these two gene therapies have differences, but the fact remains that they use the same AAV vector & that vector is what is linked to patient deaths. We are not confused about that.

One of FDA's Oncology Division has lost what is essentially the equivalent of a full drug review team. It's malignant hematology review teams are expected to have a staff less than half the intended size as more staff depart this August. insights.citeline.com/pink-sheet/age…