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, ...

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

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 ...

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 ...

Alembic Pharmaceuticals announced that it has received final approval from the U.S. Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Carbamazepine Tablets USP, ...

From my colleague Allison DeAngelis: Over the last few years, the drug industry has rushed to retool CAR-T treatments for ...

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 ...

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbamazepine Tablets USP ...

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