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While overall survival remains the desired endpoint in treating non-small cell lung cancer, progression-free survival may suffice as the primary endpoint, the FDA says. Read More
Homeopathic drugs could face greater regulatory scrutiny by the FDA, as the agency weighs whether its existing regulations and enforcement policies are sufficient to deal with the dramatic uptick in natural products on the U.S. market. Read More
Despite agreeing to pay more than $500 million to settle a lawsuit stemming from pay-to-delay actions for its blockbuster narcolepsy drug Provigil, Israeli drugmaker Teva could still face billions more in court-ordered payments. Read More
The FDA is seeking specific suggestions on potential changes to the Generic Drug User Fee Act Performance Goals and Procedures, ahead of negotiations to reauthorize the law, which expires Sept. 30, 2017. Read More
With the Prescription Drug User Fee Act set to expire in September 2017, the FDA will kick into full gear on reauthorization negotiations this June, FDA Acting Commissioner Stephen Ostroff said Monday. Read More
The FDA is taking the unusual step of pressing Genervon Biopharmaceuticals to release all data from a Phase IIa trial of its amyotrophic lateral sclerosis drug, including an analysis of changes in patients’ lung function. Read More
An Indian pharmacists group is urging the government to immediately require detailed instructions on storage temperatures on all drug labels, to prevent improper handling in the supply chain and by end users. Read More
Bristol-Myers Squibb has cut short the comparative arm of a trial of its immunotherapy drug Opdivo after interim results showed a clear benefit over chemotherapy. Read More
A global regulatory group is following the EU’s lead in recommending that drugmakers use a risk-management approach to qualify and validate manufacturing processes. Read More
The FDA should issue guidance officially adopting U.S. Pharmacopeia standards in its visual particle inspections of injectable drugs, law firm Hogan Lovells says in a Wednesday citizen petition submitted to the agency on behalf of an unnamed drugmaker. Read More