FDA

The U.S. Food and Drug Administration (FDA) on Wednesday approved Guardant Health Inc.’s (NASDAQ:GH) Guardant360 Liquid CDx test, expanding the company's blood-based comprehensive genomic profiling capabilities for patients with advanced cancer. The approval also transfers the seven...

ImmunityBio Inc. (NASDAQ:IBRX) stock is up during Wednesday’s premarket session as the company is gaining attention following the FDA’s acceptance of its supplemental Biologics License Application (sBLA) for ANKTIVA in combination with Bacillus Calmette-Guerin (BCG) for treating BCG-...

On Monday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc's (NASDAQ:AZN) Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor, for adults with hypertension whose blood pressure remains uncontrolled despite taking other antihypertensive medicines. Mineralys...

Tracey Beth Hoeg, acting head of the U.S. Food and Drug Administration‘s Center for Drug Evaluation and Research, was fired Friday after six months in the role, amid several high-level official exits from the federal public health agency. Hoeg confirmed the dismissal on X, saying the day...

Aardvark Therapeutics Inc. (NASDAQ:AARD) said the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application for ARD-101, following the company's previously disclosed voluntary program pause. ARD-101 is an oral small-molecule therapy designed...

The U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval to BeOne Medicines Ltd.‘s (NASDAQ:ONC) Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma who previously received at least two lines of systemic therapy, including a Bruton...

REGENXBIO Inc. (NASDAQ:RGNX) on Thursday released topline and interim functional data from the pivotal Phase 1/2/3 AFFINITY DUCHENNE trial evaluating RGX-202, its investigational gene therapy for Duchenne muscular dystrophy. The company said the study met its primary endpoint with high statistical...

Argenx SE – ADR (NASDAQ:ARGX) shares are up during Monday’s session as the company celebrates a recent FDA approval for its drug, VYVGART, which adult patients with generalized myasthenia gravis can use. The approval is seen as a significant advancement in treatment options, simplifying...

MoonLake Immunotherapeutics (NASDAQ:MLTX) shares are up during Monday’s trading session, trading higher as the company is reporting positive outcomes from its final pre-BLA meeting with the FDA regarding its sonelokimab (SLK) program for hidradenitis suppurativa (HS). • MoonLake...

The White House is reportedly considering naming FDA Deputy Commissioner Kyle Diamantas as acting commissioner of the Food and Drug Administration as President Donald Trump weighs removing current FDA Commissioner Marty Makary. According to a Reuters report on Saturday, Diamantas, who oversees the...

On Friday, President Donald Trump distanced himself from reports that his administration is preparing to remove Food and Drug Administration Commissioner Marty Makary. White House Weighs FDA Leadership Shake-Up Senior White House and health officials have approved plans that could replace Makary...

U.S. health officials last week discussed whether certain selective serotonin reuptake inhibitors, or SSRIs — a widely prescribed class of antidepressants — could face new restrictions as Health Secretary Robert F. Kennedy Jr. prepared a broader initiative aimed at reducing use of the medications,...

Biogen Inc. (NASDAQ:BIIB) shares are trading higher on Friday as the company is continuing its FDA review process for Leqembi Iqlik (once‑weekly lecanemab‑irmb subcutaneous injection) for early Alzheimer’s disease. • Biogen stock is showing upward movement. What’s driving...

Florida Gov. Ron DeSantis confirmed on Friday that he was prepared to sign an over-the-counter ivermectin bill, after House Republicans blocked legislation the Senate had already passed 23–15. Senate Passed, House Blocked “The ivermectin bill was passed by Republicans in the Florida Senate...

Eli Lilly and Co. (NYSE:LLY) revealed plans to inject an extra $4.5 billion into two of its Indiana manufacturing sites on Wednesday. This move escalates its total capital expansion in the state since 2020 to over $21 billion. The additional funding is intended to support the production of...