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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
The European Medicines Agency has confirmed plans to halt sales of 700 drug forms and strengths authorized based on clinical studies performed by Hyderabad, India-based GVK Biosciences. Read More
A federal appeals court Friday affirmed a lower court order preventing Actavis from replacing an older formulation of Namenda ahead of generic versions of the Alzheimer’s drug hitting the market in July. Read More
The FDA is hoping that a study of spousal communication related to direct-to-consumer prescription drug advertising will help it make better recommendations for these ads. Read More
The FDA has hit Actavis with a warning letter for making unsubstantiated claims about its Rapaflo benign prostatic hyperplasia drug on a company webpage. Read More
Johnson & Johnson will be liable for unlimited punitive damages in a bellwether trial next month alleging that Extra Strength Tylenol triggered acute liver failure leading to a woman’s death, under a federal court ruling. Read More
The FDA plans to issue a proposed rule this year streamlining requirements for fixed-dose combination prescription and over-the-counter drugs into one set of regulations, according to an updated list of priorities released Friday. Read More
California-based Amgen may soon be the first to get a new class of cholesterol-lowering biologics onto the European market, following a positive opinion from the European Medicines Agency on Friday. Read More