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The WHO granted the vaccine an emergency use listing (EUL) in November 2021 but suspended the supply in April following its inspection of the Bharat Biotech facility. Read More
The FDA sent a warning letter to Newbury Park, Calif.-based Colorful Products citing serious quality control violations at the company’s over-the-counter (OTC) drug manufacturing facility. Read More
The FDA approved Sanofi and Regeneron’s blockbuster monoclonal antibody, Dupixent (dupilumab), for patients 12 years and older with eosinophilic esophagitis, a rare chronic inflammatory disorder — making it the first FDA-approved treatment for the disease. Read More
About 100 generic medicines are likely to get their European marketing authorizations yanked following revelations of flaws in their bioequivalence studies conducted at one particular contract research organization. Read More
A proposed regulation issued by the FDA today would add two new parts to drug manufacturing regulations for medical gases focusing on labeling, current Good Manufacturing Practice (cGMP), certification and postmarket safety. Read More
The FDA issued a warning letter to Specialty Process Labs for significant deviations from current good manufacturing practices (cGMP) for active pharmaceutical ingredients (API), including failure to validate manufacturing processes and ensure uniform blends. Read More
In a new draft guidance, the FDA presses drug manufacturers to develop risk management plans to further shore up the country’s drug supply chain. Read More
The European Medicines Agency’s (EMA) human medicines committee endorsed nine new drugs during its monthly meeting held from May 16 to 19, including LFB Biotechnologies’ coagulant therapy Cevenfacta (eptacog beta (activated)) for treating congenital hemophilia. Read More
Sens. Chuck Grassley (R-Iowa), Ron Wyden (D-Ore.) and Mike Braun (R-Ind.) are urging the Federal Trade Commission (FTC) to examine how pharmacy benefit managers (PBM) affect the cost of insulin products. Read More