We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Manufacturers looking to speed up drug approvals in Europe, and ensure their products will be covered by payers, should initiate early parallel conversations with both the European Medicines Agency and the Health Technology Assessment Bodies (HTABs), the EMA says. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis and made available to patients sooner. Read More
AstraZeneca said the FDA has approved its fish oil-based cardiovascular drug Epanova (omega-3-carboxylic acids) for the treatment of adults with very high triglyceride levels. Read More
The FDA says there isn’t enough evidence to support marketing aspirin as preventing first-time heart attacks, meaning drugmakers will have to fund more studies if they want to change the agency’s mind. Read More
Longer-term clinical benefits associated with sustained soliris treatment include prevention of TMA and continued improvement in renal function. Read More
House lawmakers are seeking new ways to streamline the drug development and approval process, calling for solutions to reverse high costs of clinical trials and the slow supplemental application pathway. Read More
Mylan and Actavis are challenging the FDA’s April 24 decision to grant 180-day marketing exclusivity to Teva for a generic version of the blockbuster arthritis drug Celebrex. Read More
The FDA on Monday approved UK-based NOVA Laboratories’ oral suspension drug for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Read More