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Drug companies and a contract research organization are urging the FDA to sharpen its recommendations on how to reveal to blood cancer patients whether they’re taking placebos or the real thing in clinical trials. Read More
Drugs targeting the central nervous system take significantly longer to develop and get approved than other meds, according to a new analysis. Read More
CNS drugs were approved at a 6 percent faster clip than other drugs between 2012 and 2017, according to the report, but it’s unclear whether that trend will last. Read More
Drugs targeting the central nervous system take significantly longer to develop and get approved than other meds, according to a new analysis. Read More
The European Medicines Agency released new guidelines on developing treatments for Crohn’s disease and ulcerative colitis set to take effect Jan. 1. Read More
The agency discourages using the Crohn’s Disease Activity Index (CDAI) to assess efficacy because of questions about its reliability and validity. Read More
The European Medicines Agency released new guidelines on developing treatments for Crohn’s disease and ulcerative colitis set to take effect Jan. 1. Read More
In its fifth annual drug shortage report to Congress, the FDA called 2017 “a challenging year” with shortages up again from 2016 despite a steady overall improvement since 2011. Read More
The FDA published draft guidance to assist developers of monotherapeutic, combination and adjunctive drug treatments for major depressive disorder (MDD), offering considerations for nonclinical safety and clinical pharmacology. Read More