Latest FDA News
Biosimilars
The US Food and Drug Administration approved 50 novel drugs in 2024, continuing to outpace its global regulatory peers. 10 January 2025
American Pharma News
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Company Spotlight
MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases.
Latest News & Features of interest to FDA
Biotechnology
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will review the Biologics License Application (BLA) for CTL019 (tisagenlecleucel-T) in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia on July 12. 7 June 2017
Pharmaceutical
Scott Gottlieb has been confirmed as the new Commissioner of the US Food and Drug Administration (FDA). 10 May 2017
Biotechnology
The US Food and Drug Administration (FDA) has approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women. 9 May 2017
Pharmaceutical
The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) have published their final version of a template for investigators to use when organizing clinical trial protocols. 3 May 2017
Pharmaceutical
The US Food and Drug Administration is restricting the use of codeine and tramadol medicines in children. 21 April 2017
Pharmaceutical
A new analysis comparing the performance of the US Food and Drug Administration and the European Medicines Agency has found that the FDA approves drugs three to four months faster than its European counterpart. 13 April 2017
Generics
The US Food and Drug Administration (FDA) has warned Netherlands incorporated Mylan that unless it addresses manufacturing violations at its facility in Maharashtra, India, then the agency could withhold approval of any new applications or supplements listing the firm as a drug manufacturer. 12 April 2017
Pharmaceutical
The US Food and Drug Administration (FDA) has fully approved AstraZeneca’s non-small cell lung cancer (NSCLC) treatment Tagrisso (osimertinib), the company announced today. 31 March 2017
Pharmaceutical
President Trump's choice to head up the US Food and Drug Administration, Scott Gottlieb, is severing ties with industry in an attempt to put clear blue water between his previous life as a pharmaceutical insider and his new incarnation as FDA Commissioner. 30 March 2017
Pharmaceutical
NDA Group announced findings from its fourth annual comparison of drug approvals in the European Union and the USA, ahead of this year’s DIA EuroMeeting in Glasgow, Scotland. 29 March 2017
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