Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) and granted Priority Review designation for the investigational compound ...

Khindivi is the sole FDA-approved hydrocortisone oral solution and is available in a 1mg/ml concentration. This formulation ...

Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.

SHELTON, CT / ACCESS Newswire / June 4, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company ...

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid ...

Enantiomers, or molecule pairs that are mirror images of each other, make up more than half of FDA-approved drugs in use ...

Tenpoint Therapeutics announced that the new drug application (NDA) for its presbyopia candidate, brimochol PF, has been ...

Preclinical data has showing compelling findings for HT-KIT among patients with rare and aggressive KIT-driven cancers, ...

has accepted the New Drug Application (NDA) resubmission for investigational ND0612, a 24-hours/day, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD), for the treatment ...

ND0612 is an investigational drug-device therapy that provides a 24-hour continuous subcutaneous infusion of levodopa/carbidopa solution. The Food and Drug Administration (FDA) has accepted for review ...

The FDA has accepted for priority review the new drug application for sevabertinib (BAY 2927088) to treat certain patients with NSCLC.

The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, ...