Clinical News

Drug shortages likely after hurricanesFDA Commissioner Scott Gottlieb, MD, said that the United States is likely to see shortages on certain drugs because after Hurricanes Irma and Maria knocked out power to the islands.
FDA: Risk of blindness from compounded eye drugFDA warns that this compounded eye drug could lead to a disease that causes blindness.
Cholesterol drug misbranded, company pleads guilty
Cholesterol drug misbranded, company pleads guiltyPharma maker pleads guilty that one of its major drugs was misbranded in a federal court case brought by FDA and the US Department of Justice.
FDA alters stance on opioid addiction drugs
FDA alters stance on opioid addiction drugsFDA is advising that these 2 opioid addiction medications should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system.
FDA approves generic Tamiflu, plus 2 other new drugs
FDA approves generic Tamiflu, plus 2 other new drugsFDA approved the first generic version of oseltamivir phosphate (Tamiflu, Roche) for oral suspension to treat influenza A and B, plus 2 other noteworthy therapies.
FDA okays biosimilar for several cancers
FDA okays biosimilar for several cancersWhile FDA has approved a handful of biosimilar drugs, the agency just approved the first biosimilar that treats a variety of types of cancer.
FDA warns Pfizer’s Meridian over EpiPen flawsFDA warned about an injunction or seizure if Meridian Medical Technologies, a division of Pfizer, does not correct its problems with the EpiPen (epinephrine auto-injector).
FDA warns about deaths in cancer drug trials
FDA warns about deaths in cancer drug trialsAn increased risk of deaths for patients in clinical trials receiving this cancer drug and two other drugs led FDA to stop the clinical trials.
Will new biosimilars hurt blockbuster autoimmune drug?
Will new biosimilars hurt blockbuster autoimmune drug?New biosimilars may harm the sales of this autoimmune blockbuster.
FDA okays targeted leukemia treatmentFDA approved a targeted new drug to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.