FDA is soliciting projects to fund under a new pilot program to enhance regulatory science for biosimilars and interchangeable products.
Takeda says it will discontinue manufacturing Natpara (parathyroid hormone) for injection due to manufacturing woes that caused protein particle forma...
FDA tells Inhibrx that there is potential to pursue an accelerated approval for INBRX-101 for treating patients with emphysema due to alpha-1 antitryp...
FDA launches a Rare Disease Endpoint Advancement pilot program as called for in the PDUFA 7 reauthorization.
FDA warns Ocean, NJ-based Flawless Beauty and Skin that it is illegally distributing imported medical devices used in skin care.
FDA warns Dupo, IL-based Sterling Pharmaceutical Services about CGMP and other violations in its production of finished drugs.
FDA starts the Split Real Time Application Review pilot program called for in the PDUFA 7 reauthorization.
The U.S. Supreme Court asks the government to weigh in on Tevas appeal of a court decision in a case involving a so-called skinny label for a generic ...
