Moderna MRNA announced the FDA approval for mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, though for a ...

If approved, ziftomenib could be the first FDA-approved Menin inhibitor for relapsed/refractory acute myeloid leukemia with ...

An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib ...

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s (NASDAQ:SNY) meningococcal vaccine MenQuadfi for infants as ...

Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir ...

RxDx assay as a companion diagnostic to identify c-Met protein expression in non-squamous NSCLC patients eligible for treatment with Emrelis.

The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge ...

YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar ...

Zevra reported filling 13 new prescription enrollment forms to receive Miplyffa, raising the total to 122 enrolments through ...

The COPD approval marks the fifth Nucala has received from the FDA, following green lights in severe asthma, chronic ...

Branded drugs, including Synthroid, Lipitor, and Nexium, had a legacy use of talc, and they still contain it, Tidmarsh said ...

Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which ...