FDA publishes a guidance incorporating GDUFA 3 reauthorization performance goals for post-complete response letter clarification teleconferences.
Washington Legal Foundation says a California trial court erred in ruling that Gilead could be held liable for not developing a different HIV/AIDS dru...
CBER publishes four Standard Operating Policies and Procedures relating to application review responsibilities for various products.
Bayer pushes FDA to confirm that it will grant a 30-month stay before approving an Apotex ANDA for Bayers Astepro Allergy nasal spray.
FDA and researchers from New York University partner to design a regulatory science tool to improve the review processes for stroke rehabilitation dev...
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...
