In responses to two Republican senators, Robert Califf — the Biden administration’s nominee for FDA commissioner — provided a deeper look into the priorities he would set at the helm…

Just 6 percent of biologic drug patents actually cover the drug’s active ingredients. Source: Drug Industry Daily

The FDA has issued a warning letter to Sunstar Americas that cites several quality lapses, including problems with its water system. Source: Drug Industry Daily

Teva Pharmaceuticals has agreed to pay $420 million to settle shareholder litigation alleging the company concealed an anti-competitive scheme to fix the prices of about 50 generic drugs, according to…

Gilead Sciences has announced that it’s removing counterfeit versions of its HIV medications Biktarvy and Descovy from the U.S. supply chain following the discovery that thousands of bottles of the…

The FDA issued a warning letter to an over-the-counter (OTC) drug manufacturing facility in South Korea following a review of records that raised quality concerns about an acne treatment. Source:…

The FDA has placed clinical holds on two drugs that use the transferrin receptor to gain access to their sites of action, raising concerns about the entire approach. Source: Drug…

Bristol Myers Squibb (BMS) subsidiary Juno Therapeutics has lost a bid to persuade a U.S. appeals court to overturn its own decision tossing out a $1.2 billion patent verdict that…

The FDA needs to get much better workforce planning in place for medical products. Source: Drug Industry Daily

All is well between Eli Lilly and the FDA after the agency’s Office of Prescription Drug Promotion (OPDP) admonished the drugmaker for not submitting two direct-to-consumer TV advertisements for its…