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Presidential hopeful Hillary Clinton has unveiled a plan to rein in exorbitant drug costs for lifesaving treatments that would penalize drugmakers for price-gouging. Read More
The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
Nearly two years after the agency said that it would review its regulatory framework on off-label use, the FDA announced that it would hold a meeting Nov. 9 and 10 to involve stakeholders in the framing of guidance and regulations on unapproved uses. Read More
Drug safety label information will be available closer to its approval date now that CDER’s Office of Communications is handling label changes, CDER Director Janet Woodcock announced Thursday. Read More
Genmab has announced the FDA’s approval of Arzerra in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia. Read More
The FDA has accepted the NDA for Mitsubishi’s edaravone drug, putting it on course to be the first approved treatment for amyotrophic lateral sclerosis (ALS) in more than 20 years. Read More
The California Supreme Court ruled that state courts have the jurisdiction to hear cases filed by out-of-state residents, clearing the path for an amended suit against Bristol-Myers Squibb that contends the company’s blood-thinner Plavix led to patient injuries. Read More