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The FDA has granted Cerulean Pharma’s investigational nanoparticle drug conjugate CRLX101 orphan status for the treatment of relapsed ovarian cancer, guaranteeing the drugmaker seven years added exclusivity if the product is approved. Read More
Six years after promising a web-based alternative to its electronic submissions gateway, the FDA has launched a drug safety reporting portal for companies with a small number of adverse event reports. Read More
German drugmaker Boehringer Ingelheim has won FDA approval for Stiolto Respimat, the fourth inhaled drug that the FDA has allowed the company to market for chronic obstructive pulmonary disease. Read More
Beleaguered Indian generics maker Wockhardt is recalling 93,393 bottles of its blood pressure medicine Captopril in the U.S., after discovering the tablets failed to meet specification for thickness. Read More
India’s Supreme Court has temporarily barred Glenmark Pharmaceuticals from making new copies of Merck’s diabetes drugs Januvia and Janumet, but the Mumbai-based company may continue to sell its existing stock. Read More
Washington State Gov. Jay Inslee has signed legislation allowing pharmacists to substitute biosimilars for brandname biologics, joining a growing list of states that have passed such laws. Read More