The Latest Breaking News from FDA

The Apple Watch’s new hypertension detection feature has won FDA clearance in time for the launch of the Series 11, and will arrive on watches next week.

Tool will come to new watches announced this week – but some old ones, too

On Wednesday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc’s (NASDAQ:AZN) Koselugo (selumetinib) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN), benign, nerve sheath tumors.

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson Johnson's (NYSE:JNJ) Inlexzo (gemcitabine intravesical system) as a new treatment approach for certain types of bladder cancer patients who need additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy).

Federal agents have seized illegal vaping products nationwide as the Trump administration cracks down on items often used by teens

Top health officials under the U.S. Health and Human Services Secretary Robert F. Kennedy Jr. are intensifying efforts to gather and publicize data on potential harms caused by COVID-19 vaccines, particularly in pregnant women.

Every smartwatch brand wants to "save lives" and get people healthier. By detecting hypertension, Apple is making a major statement.

President Donald Trump has signed an order to intensify regulations on direct-to-consumer drug advertisements. The administration has accused pharmaceutical companies of providing misleading information about medications and their side effects.

The FDA said it's sending out 100 cease-and-desist letters and warning thousands of others over ads it says are "misleading."