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The drug also received Fast Track status for the treatment of patients with first-line recurrent or metastatic head and neck squamous cell carcinoma. Read More
As part of its commitments under the newly reauthorized Prescription Drug User Fee Act (PDUFA VII), the FDA has launched the Rare Disease Endpoint Advancement (RDEA) pilot that will test a new meeting system to help sponsors of rare disease clinical trials develop efficacy endpoints. Read More
With the Prescription Drug User Fee Act (PDUFA) VII and the other user fee programs now reauthorized, the FDA is announcing work on several new initiatives this week — including the Split Real-Time Application Review (STAR) pilot program. Read More
Currently idle U.S. generic drug manufacturing capacity could keep the nation’s drug supply chain “secure, robust and resilient,” according to researchers at Washington University’s Olin Business School in St. Louis. Read More
The U.S. Supreme Court has refused to hear Biogen’s argument that its patent on the blockbuster multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate) should be reinstated as part of the company’s ongoing fight with Mylan Pharmaceuticals, which has for two years marketed a generic version of the drug. Read More
Just days after Congress reauthorized the third iteration of the biosimilar user fee act, BsUFA III, the FDA has announced that it’s launching a pilot program to improve the efficiency of biosimilar product development and advance the development of interchangeable products. Read More
A European pharma group is calling on the EU to establish a mechanism comparable to the U.S.-based Priority Review voucher system to facilitate the development of new antimicrobial drugs. Read More
With reports that as many as 40 percent of Americans may have some difficulty swallowing tablets, the FDA released multiple guidances for sponsors of generic drugs on Monday, including a final guidance on how the physical attributes of generics may affect patients’ compliance with their drug regimens. Read More