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The regulator stated that the NDA requires additional clinical data to determine the most appropriate doses of the once-daily oral medication. In addition, the FDA said additional data is required

The Company has received initial regulatory approvals in Europe to initiate the ZENITH-1 exploratory clinical trial this summer. Jon Stonehouse, Chief Executive Officer said: "To complement the attractive

The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnoses or prevention

The company is developing SB208 as a broad-spectrum antifungal gel to treat superficial cutaneous fungal infections of the skin and nails such as tinea pedis and onychomycosis. Onychomycosis

The randomized Phase 2 "YOSEMITE" trial was designed to assess the efficacy and safety of demcizumab plus standard-of-care chemotherapy in first-line metastatic pancreatic cancer with the primary endpoint

The approach is based on the work of Dr. George Miller, Director of S. Arthur Localio Laboratories and Director of the Cancer Immunology Program at NYU School of

Research on the vaccine, which is currently in the development stage, was carried out by The University of Texas Medical Branch (UTMB) at Galveston, US and Brazil's Instituto

Ingrezza is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, which is claimed to be the only FDA-approved product to treat adults with TD. FDA approval was based

Takeda and NuBiyota will collaborate to advance oral microbial consortia products developed by using NuBiyota’s microbiome platform for GI indications. NuBiyota will receive an upfront payment and is