Tom Price was confirmed by the Senate as the next Secretary of HHS in a late-night Thursday vote and swiftly sworn in Friday morning by Vice President Mike Pence. Source:…

A federal appeals court temporarily suspended a permanent injunction that bars Sanofi and Regeneron from selling their cholesterol drug Praluent, pending a final ruling on an appeal. Source: Drug Industry…

A group of 31 Democratic senators have asked Kaléo to provide details on pricing of the company’s opioid overdose treatment Evzio, requesting documents on production costs and donation programs. Source:…

FDA medical officers — including those involved with product review and post-market safety monitoring across CDER, CBER and CDRH — will be exempt from the federal hiring freeze, according to…

The International Council on Harmonisation announced several new international members, in a Feb. 2 report on its November meeting in Osaka, Japan. Source: Drug Industry Daily

The FDA handed drug manufacturer Jubilant HollisterStier a Form 483 after inspecting its Kirkland, Quebec facility. Source: Drug Industry Daily

The FDA’s Office of Generic Drugs received 57 ANDAs in January, marking a nearly 76 percent decrease in submissions from the previous month, when the agency experienced a surge in…

The Trump administration is being sued over the president’s executive order requiring federal agencies to cut two regulations for every one they issue. Source: Drug Industry Daily

A California supplement maker is drawing scrutiny from the FDA for violating GMP regulations and misbranding products as drugs. Source: Drug Industry Daily

The House Oversight Committee threatened to subpoena Mylan for full documents related to price increases for its EpiPen. Source: Drug Industry Daily