Bristol-Myers Squibb’s Opdivo Approval; Mirati’...

FDA Clears AstraZeneca and Merck’s Lynparza as an Adjuvant Breast Cancer Therapy The FDA approved the AstraZeneca and Merck drug for a specific group of patients with high-risk early breast cancer after chemotherapy treatment, either before or after surgery. Lynparza cements its position as the best-selling PARP...

Sandoz Launches generic Revlimid in 19 European Countries, Bringing a Flood of Competition to BMS' Megablockbuster Since Bristol Myers Squibb acquired Celgene and its megablockbuster Revlimid, the company has been bracing for the day when the multiple myeloma superstar would face generic competition. Sandoz, a s...

Biogen-Eisai's potential Aduhelm sequel drug secured speedy review by FDA Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been secured a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process. The drug is the next in line behind the pair’s app...

Sky receives FDA clearance to market the geko™ device for venous insufficiency and ischemia  On December 16, 2021, Sky Medical Technology Ltd, a medical device company, got approval from the US Food and Drug Administration (FDA) 510(k) to market the geko™ device for growing microcirculatory bl...

Progress is driven by innovation. When it comes to developing novel medications and therapeutic biological products, the FDA's Center for Drug Evaluation and Research (CDER) assists the pharmaceutical sector at every stage of the process. CDER offers scientific and regulatory assistance needed to bring innovative m...

Naviswiss secures FDA 510k clearance for Naviplan, an advanced planning solution for hip replacement surgery  On October 21, 2021, Naviswiss, a Swiss-based medical technology company, received approval from the FDA to commercialise Naviplan in the United States. Naviplan is a digital pre-operative planning ...