The FTC is asking a Georgia federal court to remove Par Pharmaceuticals and Paddock Laboratories from an antitrust case that alleges the companies delayed the market entry of their AndroGel…

The federal government issued a subpoena to Biogen requesting information on prices, rebates and co-assistance programs for four of its therapies, according to an SEC filing by the company. Source:…

Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said. Source: Drug Industry Daily

Spain’s medicines and medical devices agency suspended manufacturing at Euro Far Alergi’s Madrid facility citing serious GMP violations. Source: Drug Industry Daily

The FDA will no longer redact the CVs of its advisory committee members, in response to a Freedom of Information Act lawsuit filed by Public Citizen last year. Source: Drug…

The Office of Management and Budget on Friday clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over…