Novartis and Lupin are seeking additional clarity on thresholds of unspecified impurities in topical ophthalmic drug products, according to comments on the FDA’s October draft guidance on the subject. Source:…
Under a new program, described in a draft guidance issued Tuesday, the FDA will expedite development and assessment of applications, including supplements, for drugs that are manufactured using a designated…
Actions and future plans by the Biden administration to impose drug price controls could prove disastrous for U.S. clinical trials and medical innovation overall, the U.S. Chamber of Commerce (CoC)…
Comments from AstraZeneca, Pfizer, Johnson & Johnson and Certara on the FDA’s draft guidance on developing peptide drugs focused on ways to categorize peptides and the potential for the drugs…
The FTC announced on Monday its intention to block Sanofi’s proposed acquisition of an exclusive license to Maze Therapeutics’ therapy in development for treatment of Pompe disease and hours later…
AdvaMed announced the establishment of a new medical imaging technology division that will advocate on behalf of large and small devicemakers, and is establishing itself as the new home for…
Getinge’s recall of its Cardiohelp for problems with its emergency drive has been identified by the FDA as a Class I recall — the most serious type of recall as…
Eight of 10 high-cost drugs — with increases that totaled $1.27 billion — had substantial price increases in 2022 that were not supported by new clinical evidence, a new report…
Teva Pharmaceuticals has asked a Colorado federal judge to keep alive its lawsuit challenging the state’s epinephrine auto-injector (epi-pen) affordability program as unconstitutional, arguing that suing in state court for…
HHS’s fall unified agenda of proposed rules for the FDA includes a new rule that revokes two old rules that have either been superseded or do not reflect current agency…