The Latest Breaking News from FDA

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

Turning Point Therapeutics, Inc. (NASDAQ: TPTX) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its lead drug candidate Repotrectinib in Patients With One Prior ROS1 Tyrosine Kinase Inhibitor and no Prior Chemotherapy.

Eisai Co Ltd (OTC:ESALY) has completed the rolling submission of the FDA marketing application under the accelerated approval for lecanemab (BAN2401) for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD. Eisai is collaborating with Biogen Inc (NASDAQ:BIIB) for drug development. Eisai has requested a Priority Review, while the lecanemab Phase 3…

Why do we have tariffs on imported formula in the middle of a shortage?

RBC Capital Markets writes that following the Advanz deal, Intercept Pharmaceuticals Inc (NASDAQ:ICPT) should be well-capitalized into make-or-break upcoming readouts for obeticholic acid (OCA) in NASH, with REGENERATE re-analyses on deck, REVERSE reading in the next quarter. The analysts say it remains challenging to get visibility on how the efficacy/safety analyses will look,…

A small number of COVID-19 patients are relapsing after taking Pfizer's antiviral pill, raising questions about the drug at the center of the U.S. response effort

US customers started deluging Mexican border pharmacies after Texas passed an anti-abortion law last fall. A two-pill combination costs about $400 and does not require a doctor's prescription.

Strained supplies are further exacerbated after a recall by manufacturer Abbott, experts say

DENVER — The nicotine landscape in Colorado is likely to change in the near future, but how much depends on what lawmakers do in the final days of this year’s legislative session.

LogicBio Therapeutics Inc (NASDAQ: LOGC) shares are trading higher by 63.48% at $0.81 after the company announced the FDA lifted the clinical hold on its LB-001 Investigational New Drug Application, allowing patient enrollment to resume in the Phase 1/2 SUNRISE trial for pediatric patients with methylmaloni

In today's Inverse Daily, read science stories on NASA’s Moon woes, hidden delights under the Antarctica ice sheet, and female reproductive healthcare.