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The FDA has updated its guidance on refuse-to-receive criteria for ANDAs to include a reference to the Office of Pharmaceutical Quality, which didn’t exist when the guidance was finalized. Read More
Germany’s healthcare cost watchdog has recommended against paying for Celgene’s Otezla, citing a lack of evidence that the psoriasis drug offers added benefit over available therapies. Read More
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