Articaine Hydrochloride/Epinephrine Bitartrate

ADZYNMA (ADAMTS13, recombinant-krhn) Neutralizing antibodies with fatal outcome FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on November 21, 2025: FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura Asceniv (immune globulin intravenous, human-slra) Increased hypersensitivity reactions in patients receiving certain product lot FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on October 28, 2025: Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions Benlysta (belimumab) injection Severe cutaneous adverse reactions FDA is evaluating the need for regulatory action. Braftovi (encorafenib) capsules Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablet Sarcoidosis FDA is evaluating the need for regulatory action. Cabometyx (cabozantinib) tablets Cometriq (cabozantinib) capsules Lenvima (lenvatinib) capsules Thrombotic microangiopathy FDA is evaluating the need for regulatory action. Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Sarcoidosis FDA is evaluating the need for regulatory action. ELEVIDYS (delandistrogene moxeparvovec-rokl) Mesenteric vein thrombosis following product-related acute liver injury The "Warnings and Precautions" and "Adverse Reactions - Postmarketing Experience" sections of the labeling for Elevidys were updated in November 2025 to include life-threatening mesenteric vein thrombosis. FDA Safety Communication was issued on November 14, 2025: FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients Firmagon (degarelix for injection) Myfembree (relugolix, estradiol, and norethindrone acetate) tablets Orgovyx (relugolix) tablets Drug interaction FDA is evaluating the need for regulatory action. Ifex (ifosfamide) injection Pregnancy, puerperium and perinatal conditions FDA is evaluating the need for regulatory action. Ogsiveo (nirogacestat) tablets Visual impairment FDA is evaluating the need for regulatory action. Orgovyx (relugolix) tablets Hypertension FDA is evaluating the need for regulatory action. Rezzayo (rezafungin for injection) Hypersensitivity The "Warnings and Precautions", "Adverse Reactions" and "Patient Counseling Information" sections of the labeling were updated in December 2025 to include information about hypersensitivity reactions, including anaphylaxis. Rezzayo labeling Septocaine (articaine hydrochloride and epinephrine injection) Mepivacaine hydrochloride injection (a particular generic product) Wrong drug administered FDA is evaluating the need for regulatory action. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.