Malaria prevention drug Arakoda wins FDA approval

By Michael FitzhughStaff Writer For the first time in more than 18 years, the FDA has approved a new drug for malaria prevention. Washington-based 60 Degrees Pharmaceuticals LLC (60P), which got a green light to market Arakoda (tafenoquine) tablets for adults, said the approval marks the culmination of more than 30 years of R&D with […]

FDA Grants Orphan Drug Status to AGT-184 for Sanfilippo Type A

FDA Grants Orphan Drug Status to AGT-184 for Sanfilippo Type A

AGT-184 has been granted orphan drug designation for the treatment of Sanfilippo syndrome type A by the U.S. Food and Drug Aministration. Sanfilippo syndrome type A is caused by mutations in the gene that provides instructions to make the enzyme N-sulfoglucosamine sulfohydrolase (SGSH). This leads to the accumulation of a complex sugar molecule called heparan sulfate within the brain and […]

FDA Requires a Class-Wide Label Changes of Fluoroquinolones

FDA Requires a Class-Wide Label Changes of Fluoroquinolones Aug 8, 2018 | Tianyuan Hu | Research & Policy by CC Image Courtesy of Stephen Cummings on Flickr   On July 10th, 2018, the U.S. Food and Drug Administration (FDA) reinforced the warning of drug safety information by making changes to the safety labels for fluoroquinolones […]

Athenex (ATNX) Reports FDA Clearance to Import Potassium Chloride Injection Concentrate to Address US Drug …

Athenex (ATNX) Reports FDA Clearance to Import Potassium Chloride Injection Concentrate to Address US Drug …

FREE Breaking News Alerts from StreetInsider.com! StreetInsider.com Top Tickers, 8/9/2018 August 9, 2018 9:01 AM EDT Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here. Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment […]

FDA: Hepatitis C Drug Labeling Updated to Include New Clinical Data

FDA: Hepatitis C Drug Labeling Updated to Include New Clinical Data

The FDA has approved updates to the labeling for hepatitis C virus (HCV) drug glecaprevir and pibrentasvir (Mavyret) to include new data from 2 clinical studies, according to a press release.   Labeling revisions include updates to the dosing recommendations, as well as safety and efficacy outcomes data from the HCV/HIV-1 coinfection study (M14-730) and […]

Surface Oncology's SRF231 Granted Orphan Drug Status for Treatment of Multiple Myeloma

Surface Oncology's SRF231 Granted Orphan Drug Status for Treatment of Multiple Myeloma

SRF231, an experimental anti-CD47 immunotherapy candidate developed by Surface Oncology, was granted orphan drug status by the U.S. Food and Drug Administration for the treatment of multiple myeloma. The designation is granted by the FDA’s Office of Orphan Products Development (OOPD) to investigational therapies intended to treat rare diseases that affect fewer than 200,000 people in […]