The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new commissioner described as a “one-size-fits-all regulatory framework.”

FDA FLAGS SEVERE ITCH — Patients who stop using the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) may experience rare but severe itching after longtime use, the FDA has cautioned.

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of serious illness

FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers for annually updating their Covid-19 shots.

US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly requirement for drugmakers, though they will still be available for millions of high-risk Americans.

Private equity ownership of psychiatric hospitals grew rapidly from 2013 to 2021, but the quality of care did not diminish when compared to facilities not owned by private equity, according to a JAMA Psychiatry study published yesterday.

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain approvals. | FDA Commissioner Marty Makary, M.D., and CBER head Vinay Prasad, M.D.

Trump admin's new FDA update limits annual COVID shots to high-risk groups, ending routine access for healthy kids and adults.