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Sponsors hoping to use equivalence criteria in analyzing bioequivalence (BE) studies for their drug applications just got more details on how the FDA wants them to undertake that. Read More
Johnson & Johnson (J&J) has sued Amgen for allegedly violating its patent protections for blockbuster Stelara (ustekinumab) — a biologic FDA-approved for treating ulcerative colitis, psoriatic arthritis, plaque psoriasis and Crohn’s disease, among other indications. Read More
The European Medicines Agency (EMA)’s safety committee has recommended withdrawing medications containing pholcodine, an opioid active ingredient used alone or in combination with other substances, to treat dry cough, cold and flu symptoms. Read More
The most challenging drug shortages the U.S. faces are not the new ones that crop up from illnesses like COVID-19 or the current spike in respiratory illnesses. Rather, the shortages that have been ongoing for years cause the FDA the most strife. Read More
A drug candidate developed by Sanofi and the Drugs for Neglected Diseases initiative (DNDi) has shown very high efficacy in treating sleeping sickness, a sometimes lethal condition that is endemic across Sub-Saharan Africa. Read More
In a deal set to strengthen two different clinical research platforms, Bluebird Bio has sold one of its rare pediatric disease priority review vouchers (PRV) to the immunology company Argenx for $102 million. Read More