The Latest Breaking News from FDA

ESSA Pharma Inc (NASDAQ:EPIX) presented clinical results from the Phase 1a dose-escalation study of EPI-7386 as a monotherapy for metastatic castration-resistant prostate cancer (mCRPC) resistant to current standard-of-care therapies.  The initial data from 36 patients demonstrate that EPI-7386 was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated initial anti-tumor activity in a heavily…

Gilead Sciences (NASDAQ: GILD) resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection.

Three days after the U.S. Supreme Court struck down Roe v. Wade in one of the most potentially impactful rulings of the last century, a handful of women's health stocks are on the move on Monday in response to the news.

The Food and Drug Administration could be nearing a decision on Axsome Therapeutics' depression treatment, and AXSM stock rocketed Monday.

Most abortions in the US and overseas involve pills that can be taken at home, but GOP lawmakers have launched a new war on drugs, Alex Woodward reports

U.S. health authorities are facing a critical decision: whether to offer new COVID-19 booster shots this fall that are modified to better match the latest changes of the shape-shifting coronavirus

Here's a roundup of top developments in the biotech space over the last 24 hours:

Shares of Tobacco giant Altria (MO), a significant stakeholder of Juul Labs, slid last week on the news of the FDA preparing to order removing e-cigarette maker Juul’s products from the U.S. market. However, MO rebounded the following day as investors did not foresee any significant impact of this development…

Axsome Therapeutics Inc (NASDAQ: AXSM) shares rallied 40% on Monday morning after the company received some positive news from the U.S. Food and Drug Administration regarding its AXS-05 novel treatment for MDD (depression).