The US FDA (Food and Drug Administration) has accepted for review BeiGene’s Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab to treat patients with reoccurring locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)...
The US FDA (Food and Drug Administration) has granted Ohio-based pharmaceutical company Soin Therapeutics orphan drug status for low dose naltrexone (LDN) for the treatment of complex regional pain syndrome (CRPS). Complex Regional Pain Syndrome is characterized by...
The US FDA (Food and Drug Administration) has asked Eli Lilly & Co, Pfizer, and AbbVie, to inform consumers about potential risks relating to their high-profile Janus kinase (JAK) inhibitor medications. The FDA has ordered label warnings that list a heightened...
Eagle Pharmaceuticals have been granted their U.S. Patent No. 11,103,483 titled, “Formulations of Bendamustine”, by the U.S. Patent and Trademark Office (USPTO). Eagle plans to submit this patent to be included in the FDA’s (Food and Drug Administration’s) Orange Book...
The US FDA (Food and Drug Administration) has expanded their approval of brivaracetam (Briviact, UCB) to now be used as both a monotherapy or adjunctive therapy for pediatric patients, as young as 1 month old, who suffer with partial-onset seizures, meaning that all...
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