Eloxx Pharmaceuticals Announces FDA Grant of Orphan-Drug Designation for Investigational Drug ELX-02 for …

Eloxx Pharmaceuticals Announces FDA Grant of Orphan-Drug Designation for Investigational Drug ELX-02 for …

WALTHAM, Mass., April 27, 2018 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. (“Eloxx”), (NASDAQ:ELOX), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis, cystinosis and other diseases caused by nonsense mutations limiting production of functional proteins, today announced that it has received orphan-drug designation from the Food and […]

FDA fast tracks IBS-D drug candidate

Biopharmaceutical company OrphoMed announced that the FDA has granted Fast Track status to speed development of its drug candidate for diarrhea-predominant irritable bowel syndrome. ORP-101, a buprenorphine dimer therapeutic, is a peripherally active partial mu opioid receptor agonist and K opioid receptor antagonist designed to ease colonic hypersensitivity stemming from intestinal hyperalgesia and motility dysfunction […]

US FDA panel recommends approval of cannabis-derived drug for the first time

US FDA panel recommends approval of cannabis-derived drug for the first time

US FDA panel recommends approval of cannabis-derived drug for the first time Source: Shutterstock.com Following a US Food and Drug Administration expert panel vote, Epidiolex could become the first prescription cannabidiol in the United States A US Food and Drug Administration (FDA) expert panel has voted in favour of approving the cannabinoid medication Epidiolex (cannabidiol) for the treatment […]

Gene Therapy MYO-101 Receives FDA's Orphan Drug Status for LGMD2E Treatment

Gene Therapy MYO-101 Receives FDA's Orphan Drug Status for LGMD2E Treatment

The U.S. Food and Drug Administration (FDA) granted orphan drug status to MYO-101, a gene therapy being developed by Myonexus Therapeutics for the treatment of limb girdle muscular dystrophy type 2E (LGMD2E) . The FDA’s orphan drug designation is recognition of the potential of MYO-101 for the treatment of this rare disease, which has no approved therapies. The […]

CBD oil product moves toward FDA approval

CBD oil product moves toward FDA approval

BOISE – Cannabidiol, also known as CBD oil, is one step closer to pharmacy shelves. An FDA advisory panel voted unanimously in favor of the experimental medication known as Epidiolex, a drug derived from the cannabis plant, but contains no traces of THC or the compound that gets you high in marijuana. “We think it’s […]

FDA Panel Votes To Approve Marijuana-Based Drug For Epilepsy

FDA Panel Votes To Approve Marijuana-Based Drug For Epilepsy

FDA Panel Votes To Approve Marijuana-Based Drug For Epilepsy  Forbes FDA committee recommends cannabis-based drug  NBCNews.com Marijuana-based epilepsy drug could soon get federal approval, a historic first  USA TODAY The Biology and Potential Therapeutic Effects of Cannabidiol | National Institute on Drug Abuse (NIDA)  National Institute on Drug Abuse Marijuana-derived drug for epilepsy gets FDA committee recommendation  CNN Full coverage […]

FDA Panels Vote to Add Aspirin Warning to Naproxen Label

FDA Panels Vote to Add Aspirin Warning to Naproxen Label

Two US Food and Drug Administration (FDA) panels voted to include a warning on the naproxen nonprescription Drug Facts label about the interaction between aspirin and naproxen, and to make no changes to the current ibuprofen nonprescription Drug Facts label that already warns against its use with aspirin, at a joint meeting April 25. Seven […]

The FDA Moves One Step Closer To An Approved Cannabis Drug

The FDA Moves One Step Closer To An Approved Cannabis Drug

Is the U.S. Food and Drug Administration (FDA) changing its stance on medical cannabis? It would seem so since the agency will likely approve Epidiolex, a CBD extract epilepsy drug this summer. If approved, the drug would mark the first cannabis drug made from the plant. GW Pharmaceuticals, plc (NASDAQ: GWPH) is a British drugmaker; […]