125 results

• Multiple Myeloma Drug Side Effects Downplayed in Clinical Trials, Study Warns

  November 14, 2023

  Martha Garcia

  A new study warns that multiple myeloma drug clinical trials often downplay the severity of side effects and adverse results, Johns Hopkins researchers warn.

• Merck Concealed Problems with Gardasil HPV Vaccine, Lawsuit Alleges

  November 2, 2023

  Irvin Jackson

  A Gardasil HPV vaccine lawsuit claims a Nevada man suffered a host of injuries, including migraines and hair loss, due to Merck's efforts to conceal Gardasil side effects from federal regulators and the medical community.

• FDA Seeks to Improve Postapproval Safety Studies for Drugs Used During Pregnancy

  September 12, 2023

  Martha Garcia

  The FDA has announced plans to improve postmarketing studies on the effects of medication on pregnant women, in order to improve drug safety and warning labels.

• Injectafer Fails to Prevent Heart Failure in Patients with Iron Deficiency, Study Finds

  August 29, 2023

  Irvin Jackson

  A new study found that Injectafer failed to help patients with heart failure live longer or avoid hospitalization for heart problems.

• Tecentriq and Avastin Liver Cancer Combo Linked to Patient Deaths in Early Trials

  April 18, 2023

  Martha Garcia

  Some patient deaths have been linked to a clinical trial using a combination of Tecentriq and Avastin to prevent the return of liver cancer.

• New Clinical Data Shows Abiomed Impella RP Heart Pump is Safe, Despite Concerns Over Patient Deaths: FDA

  December 6, 2022

  Russell Maas

  The FDA has released clinical trial data on Abiomed Impella RP Heart Pump Systems, declaring the device safe, but updated its warning label to recommend it only be used on certain patients.

• GSK Removes Blenrep From U.S. Market, Due Poor Clinical Trial Performance for Multiple Myeloma Drug

  November 23, 2022

  Irvin Jackson

  The multiple myeloma drug Blenrep is being removed from the U.S. market after the fast-tracked cancer drug failed to perform in a recent clinical trial.

• FDA Calls for Restrictions on Ovarian Cancer Drug Rubraca Due to High Mortality Rates

  November 18, 2022

  Irvin Jackson

  The FDA is seeking restrictions on the ovarian cancer drug Rubraca, following data indicating it may increase the risk of death in some patients.

• FDA Issues New Draft Guidance on Children’s Use in Clinical Trials

  September 26, 2022

  Martha Garcia

  The FDA has proposed new guidelines for safely including children in clinical trials.

• Pediatric Heart Devices Often Approved By FDA Without Clinical Trials Involving Children: Study

  August 15, 2022

  Irvin Jackson

  A new study finds that many children's heart implants are approved without researchers actually knowing the effect of those devices on children's bodies.