A television advertisement for the Orexigen Therapeutics weight loss drug Contrave (naltrexone HCl and bupropion HCl) drew a warning from the FDA’s Office of Prescription Drug Promotion (OPDP), the office’s…

The European Medicines Agency has issued a new draft guideline on reporting breaches of clinical trial protocols. Source: Drug Industry Daily

An FDA advisory committee recommended Wednesday that the agency approve two NDAs, one in breast cancer and one in sickle cell disease. Source: Drug Industry Daily

FDA Commissioner Scott Gottlieb pitches the agency’s proposed fiscal 2018 budget to House appropriators on Capitol Hill today, as industry and other stakeholders voice their concerns over the impact of…

The FDA warned Chinese API manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Materials for inadequate quality management and record-keeping. Source: Drug Industry Daily

The FDA has warned that water systems used by manufacturers of non-sterile, water-based drugs are at risk of contamination from Burkholderia cepacia, a pathogen resistant to a wide range of…

In a first, the FDA granted an indication to a cancer immunotherapy based on a tumor’s genetic makeup, regardless of disease site or tissue. Source: Drug Industry Daily

The U.S. Supreme Court ruled that patent infringement lawsuits may only be filed where defendant companies are incorporated, and not simply in any location where their products are sold —…

Scott Gottlieb, in one of his first official acts as FDA commissioner, established an opioid policy steering committee to review the agency’s drug review policies and explore possible actions to…

President Trump’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission of ensuring the safety of drugs, which would cut its federal spending by…