The Latest Breaking News from FDA

Federal regulators have detected possible radioactive contamination in spices exported from Indonesia

This week the FDA approved the generic drug as a treatment for autism – a move that shocked health experts

The U.S. Food and Drug Administration (FDA) on Friday approved Regeneron Pharmaceuticals, Inc.’s (NASDAQ: REGN) Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH).

U.S. stocks were higher, with the Dow Jones index gaining more than 200 points on Friday.

On Thursday, the U.S. Food and Drug Administration (FDA) approved Eli Lilly and Co.’s (NYSE: LLY) Inluriyo (imlunestrant) for adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).

Harrow, Inc. (NASDAQ: HROW), a U.S.-based provider of ophthalmic disease management solutions, announced on Friday that it has agreed to acquire Melt Pharmaceuticals, Inc., a clinical-stage company developing non-opioid, non-IV sedation therapies for hospitals and outpatient care.

The Trump administration is facing conflicting political pressures over Kennedy's recent move.

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Biogen Inc.’s (NASDAQ: BIIB) supplemental New Drug Application (sNDA) for the high-dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA).

Shares of Capricor Therapeutics Inc. (NASDAQ: CAPR) are up Thursday after the company announced progress regarding one of its rare disease therapeutics. The biotech company’s stock jumped 18% immediately following the news.