The Latest Breaking News from FDA

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.

Want to live a longer, healthier life? Here are some surprising foods to enjoy (coffee!) and to avoid (some types of spinach!).

Medication abortions have become vital for some patients in states with abortion bans

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) released topline results from its Phase 3 registrational clinical trial (the RECONNECT Study) of ZYN002 in Fragile X syndrome (FXS).

In a landmark clinical trial, uniQure's gene therapy AMT-130 slowed Huntington's disease progression by 75% over 3 years. The one-time treatment may mark the first disease-modifying therapy for this incurable neurodegenerative condition.

A Trump administration decision to repurpose an old chemotherapy drug for autism has surprised many experts — including the physician who recently proposed the idea