A District of Columbia court upheld the FDA’s approval of an Abilify competitor, rejecting a challenge from Otsuka Pharmaceutical. Source: Drug Industry Daily

The FDA opened the doors to a dramatic new method for treating cancer — the genetic modification of a patient’s immune cells to fight the disease — by granting approval…

The FDA flagged a Hetero Labs drugmaking plant near Hyderabad, India for multiple violations of good manufacturing practice standards. Source: Drug Industry Daily

A federal judge shut down efforts by Eli Lilly to throw out a $20 million patent infringement verdict against the drugmaker. Source: Drug Industry Daily

A Pennsylvania district court refused to certify a group of corporate and institutional drug purchasers as plaintiffs in a class-action antitrust suit against several drugmakers — saying the approximately two-dozen…

The FDA revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from…

A Tennessee compounding pharmacy fell short of standards for aseptic production in making sterile drugs, the FDA said. Source: Drug Industry Daily

A federal task force to study pain management and prescription painkillers should get under way soon, HHS said in a Federal Register filing Monday. Source: Drug Industry Daily

FDA Commissioner Scott Gottlieb announced moves to crack down on illicit marketers of stem-cell therapies while also pledging to foster ethical innovation in the field. Source: Drug Industry Daily

The FDA released updated GDUFA program fees for the 2018 fiscal year that come with a big hike in ANDA fees and include, for the first time, annual fees for…