FDA grants Nohla Therapeutics a fast track designation for dilanubicel (NLA101) for patients with high-risk hematologic malignancies receiving an allo...
FDA issues Pain Therapeutics a complete response letter for Remoxy, an abuse-deterrent, extended-release form of oxycodone.
FDA Review posts the agency-related Federal Register notices for the week ending 8/3/2018.
An FDA safety alert warns that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung cond...
FDA grants PharmaMar an orphan drug designation for lurbinectedin and its use in treating small cell lung cancer.
FDA commissioner Scott Gottlieb says the agency is prioritizing its efforts to help product developers bring novel nicotine replacement therapy drugs ...
Federal Register notice: FDA submits to OMB an information collection extension for Medical Device Recall Authority (OMB Control Number 0910-0432).
FDA releases a guidance entitled: Medical Device User Fee Small Business Qualification and Certification.