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Because the facility’s reports lacked key information, the agency was only able to link a small percentage of the adverse events to the use of compounded hormone pellets containing testosterone. Read More
The Drug Enforcement Administration (DEA) has recommended that production of five prominent opioids should be cut significantly next year to lower risks of diversion and misuse. Read More
The U.S. Patent Trial and Appeals Board (PTAB) has agreed to conduct an inter partes review of two of Amgen’s patents on the chemotherapy drug Neupogen (filgrastim). Read More
CDER Director Janet Woodcock announced Friday that the FDA is investigating an impurity in certain heartburn drugs previously found in blood pressure drugs. Read More
An FDA advisory committee voted to Friday in favor of the risk-benefit profile of Aimmune Therapeutics’ peanut allergy therapy Palforzia (AR101). Read More