The Latest Breaking News from FDA

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The impact of Robert F Kennedy Jr on US health organisations will affect research funding and access to medicines but may force Australia to step up, say experts

On Thursday, the U.S. Food and Drug Administration (FDA) approved Crinetics Pharmaceuticals, Inc.’s (NASDAQ: CRNX) Palsonify (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

Organogenesis Holdings Inc. (NASDAQ: ORGO) shared topline data on Thursday from the second Phase 3 randomized controlled trial (RCT) of ReNu, a cryopreserved amniotic suspension allograft (ASA) for the management of symptoms associated with knee osteoarthritis (OA).

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.