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The senator is concerned that GSK “did not appear to prepare contingency plans to ensure that sufficient supplies would be available for all patients who fall within the CDC’s recommended guidelines.” Read More
The FDA denied a United Therapeutics petition urging the agency to reject ANDAs for combination products referencing the company’s hypertension drug Tyvaso (treprostinil). Read More
FDA officials will work with medical societies to come up with opioid-prescribing guidelines that regulators hope will strike a balance between the needs of chronic pain suffering and the need to protect people from addiction, Commissioner Scott Gottlieb said Monday. Read More
Although the jury took AbbVie’s side in October regarding the claim of strict liability, it also found that the company was negligent and falsely represented the safety and effectiveness of AndroGel. Read More
An Illinois federal judge canned a $140 million verdict against AbbVie and ordered a new trial involving its testosterone replacement therapy, AndroGel, after ruling the jury’s findings were contradictory. Read More
The FDA released draft guidance outlining the information sponsors should include on the Indications and Usage section of drug and biologics labeling. Read More
The agency will respond to 90 percent of priority major ANDA amendments within six months in cases where preapproval inspection is not required. Read More
The allegations “suggest that PBMs and drug distributors are acting to maintain high list prices in order to maintain high profit margins, potentially raising antitrust concerns,” the June 29 letters state. Read More