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“With time running out we hope Parliament will come together and quickly find a solution to the stalemate,” said ABPI Chief Executive Mike Thompson. Read More
Companies should have to report the problem causing the manufacturing interruption, the degree of shortage and how long it’s expected to last, the association said. Read More
The FDA issued Immunomedics a complete response letter for a BLA seeking accelerated approval for its antibody-based breast cancer treatment, sacituzumab govitecan, for patients who have tried at least two prior treatments. Read More
Marking the end of the fourth week of the partial government shutdown, FDA Commissioner Scott Gottlieb said the agency will be forced to furlough drug reviewers as user fee funding runs out. Read More
FDA Commissioner Scott Gottlieb announced on Thursday that the agency has developed easy-to-understand model drug facts labels (DFLs) to encourage drugmakers to develop an OTC version of the opioid overdose treatment naloxone. Read More
Aimovig is the first treatment that targets the process caused by proteins in which blood vessels in the brain swell and lead to migraine symptoms. Read More
“Specific statutes grant the state and federal government authority to bring these kinds of suits without meeting the ordinary burdens of individual civil plaintiffs,” the judge said. Read More