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Outlook Therapeutics announced that it has submitted a Special Protocol Assessment (SPA) request to the FDA regarding the required additional adequate and well-controlled study of ONS-5010.  An SPA is a process in which sponsors ask to meet with FDA to reach agreement on th...

Roche announced that the FDA has accepted for priority review its Biologics License Application (BLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods.  The BLA relates t...

MSD announced that the US FDA has accepted for priority review its new Biologics License Application (BLA) for V116, its investigational 21-valent pneumococcal conjugate vaccine for invasive pneumococcal disease and pneumococcal pneumonia in adults.  The FDA has set a Presc...

Korea Biomed reported that the Ministry of Food and Drug Safety (MFDS) has imposed a six week suspension of Samsung Bioepis’ completed clinical trials of SB15, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the report Samsung Bioepis altered the approved vali...

Korea Biomed reported that LG Chem’s Xelenka®, biosimilar to AbbVie’s Humira® (adalimumab), has been approved by the Korean Ministry of Food and Drug Safety to treat rheumatoid arthritis, psoriatic arthritis, uveitis in adults, Crohn’s disease, and juvenile idiopathic...

Merck announced that the FDA has approved Keytruda® in combination with Pfizer (previously Seagen)/Astellas’ Padcev® (enfortumab vedotin-ejfv) an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.

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Korea Biomedical Review reported that MSD Korea’s Tukysa® (tucatinib) was approved by Korea’s Ministry of Food and Drug Safety to treat HER2 (human epidermal growth factor receptor)-positive locally advanced or metastatic breast cancer that has recurred after at least...