A new pill, tavapadon, has shown potential in easing Parkinson’s symptoms while limiting side effects. In patients taking at ...

The FDA previously granted breakthrough therapy designation to ziftomenib for relapsed/refractory NPM1-mutant AML.

Tenpoint Therapeutics submitted a new drug application to the FDA for Brimochol PF, an eye drop for presbyopia treatment, ...

Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura ...

EVM14, an mRNA cancer vaccine, received FDA clearance for investigational new drug application, advancing Everest's mRNA technology to global clinical trials. Preclinical studies showed EVM14 induces ...

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The FDA announced a shift away from animal testing for drug approval, citing advanced alternatives like AI and organoids ...

has accepted its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with ...

NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company”), and a leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine ...

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

The FDA laid out a three-year roadmap to phase out animal toxicity testing in drug research. In addition to organoids and lab ...

The U.S. Food and Drug Administration said on Thursday it plans to replace animal testing in the development of monoclonal ...