145 results

• Ocaliva Market Withdrawal To Take Final Effect on Nov. 14

  October 21, 2025

  Irvin Jackson

  The recalled liver disease drug Ocaliva will no longer be available to patients after November 14, following its rejection by the FDA over liver injury risks.

• Ocaliva Recall Issued Due to Liver Injury Risks

  September 12, 2025

  Irvin Jackson

  Intercept has announced it is removing the liver disease drug Ocaliva from the market after the FDA determined it does more harm than good.

• Skysona Blood Cancer Side Effects Lead to New FDA Restrictions

  August 11, 2025

  Martha Garcia

  The FDA has added a black box warning to the gene therapy drug Skysona after discovering more patients developed blood cancer than previously believed.

• FDA Warns of Ocaliva Liver Injury Risks Linked to Autoimmune Disorder Drug

  December 13, 2024

  Martha Garcia

  Federal regulators warns that the autoimmune treatment Ocaliva has been linked to liver damage and failure, resulting in patient deaths and the need for transplants.

• Andexxa Blood Clot Risks Lead to FDA Questions Regarding Safety of the Reversal Agent for Xarelto, Eliquis

  November 21, 2024

  Irvin Jackson

  Safety concerns linked to Andexxa, the reversal agent for newer blood thinners like Xarelto and Eliquis, will be discussed at an FDA advisory panel meeting today, after postmarketing studies indicated the drug doubled the risks of blood clots and death.

• Eli Lilly Claims Kisunla Brain Swelling Side Effects Can Be Reduced With Modified Dosing Schedule

  November 4, 2024

  Irvin Jackson

  Makers of the new Alzheimer's disease drug Kisunla have developed a new dosing schedule, which may reduce the risk of brain swelling.

• Oxbryta Lawsuit Filed Over Vaso-Occlusive Crisis (VOC) from Recalled Sickle Cell Disease Drug

  October 28, 2024

  Irvin Jackson

  Illinois man indicates he suffered a stroke, vision loss and hospitalization due to the side effects of Oxbryta, which is a sickle cell disease medication recalled last month.

• Eisai Never Told Patients in Leqembi Clinical Trials They Faced Higher Risk of Brain Bleeds: NYT

  October 25, 2024

  Martha Garcia

  New York Times investigative report reveals that the manufacturer of the Alzheimer’s disease drug Leqembi failed to inform test subjects that they had genetic markers making them more susceptible to brain bleeds and death if they took the medication.

• FDA Advisors Vote for Restrictions on Opdivo, Keytruda, Similar Stomach Cancer Drugs

  September 30, 2024

  Irvin Jackson

  Independent scientific advisory board is calling for restrictions on stomach cancer drugs like Keytruda and Opdivo, saying they do little to extend the lives of certain cancer patients.

• Oxbryta Recall Announced After Studies Show Sickle Cell Drug’s Risks Outweigh Benefits

  September 26, 2024

  Martha Garcia

  Pfizer announces worldwide recall for the sickle cell anemia drug Oxbryta, after reports of eight patient deaths and a safety review by European regulators.