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The FDA has approved 35 novel new drugs so far this year, up from 27 products last year, with officials touting 2014 as the best year ever for rare disease treatment approvals. Read More
Merck’s new Gardasil 9 human papillomavirus vaccine won FDA approval to prevent various cancers and other illnesses caused by the sexually transmitted disease in young men and women. Read More
Central nervous system drugs that treat conditions such as Alzheimer’s and Parkinson’s disease lag behind other drugs in clinical development and approval times, a recent report finds. Read More
The European Medicines Agency is lending support to an initiative to qualify biomarkers that can provide early warning of an investigational compound’s risks of causing drug-induced kidney injuries. Read More
A House bill would for the first time require drugmakers to create and disclose an expanded access policy in exchange for receiving breakthrough therapy designation, redeeming a priority review voucher or having the drug become a qualified infectious disease product. Read More
European regulators have approved AstraZeneca and Nektar Therapeutics’ opioid-induced constipation drug Moventig for adults that have not responded to laxatives. Read More
The FDA this week approved two drugs for rare bone marrow cancers: Amgen’s Blincyto for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (ALL) and Incyte’s Jakafi for a new indication to treat polycythemia vera. Read More