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The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
The FDA on Friday approved Wellstat Therapeutics’s Xuriden to treat a rare metabolic disorder known as hereditary orotic aciduria, landing the company a rare pediatric disease priority review voucher. Read More
Acadia Pharmaceuticals Wednesday filed an NDA with the FDA for Nuplazid, a product that, if approved, would be a first-in-class drug and the first specific treatment for Parkinson’s disease psychosis. Read More
The FDA has approved Merck’s anti-nausea and vomiting drug Emend for children undergoing chemotherapy, making the drug the first and only NK1 receptor antagonist for this indication. Read More
The FDA has granted priority review for Bristol-Myers Squibb and AbbVie’s Empliciti for the treatment of multiple myeloma in patients who have received one or more previous therapies — giving it a PDUFA date of Feb. 29, 2016. Read More
Australian regulators have approved Hospira’s Inflectra as the country’s first monoclonal antibody biosimilar, a version of Janssen’s autoimmune disease therapy Remicade. Read More
Swiss regulators have approved Exelixis’ cobimetinib for use in combination with Genentech’s Zelboraf to treat advanced melanoma — allowing the company to begin marketing the drug while it awaits regulatory decisions in the U.S. and EU. Read More