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.

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

In Actavis Labs. FL, Inc. v. U.S.  (“Actavis”), a recent precedential decision, the Federal Circuit answered an important ...

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

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

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 ...

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, ...

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

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 ...