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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The FDA released draft guidance outlining the information sponsors should include on the Indications and Usage section of drug and biologics labeling.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
The U.S. Attorney for the Southern District of New York filed a lawsuit against an herbal drug manufacturer for selling unapproved drugs using claims that they can cure or prevent conditions including diabetes, syphilis, arthritis, cancer, heart disease and asthma. Read More
The FDA released final guidance Tuesday spelling out its review goals for amendments to abbreviated new drug applications and prior approval supplements under GDUFA II. Read More
Nearly nine in 10 professionals who prescribed Mallinckrodt’s HP Acthar gel (repository corticotropin) to Medicare patients in 2015 received some compensation from the company, a new study by Oregon researchers claims. Read More