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Faced with defending its COVID-19 vaccine in the face of troubling side effects, Moderna held a conference call late last week to discuss the risk of heart inflammation in young people. Read More
“All of the recently published cases related to Aduhelm are under careful review as well as medical evaluation, including the fatal case of a 75-year-old patient,” said the company. Read More
The main substance in Covis Pharma’s premature birth drug Makena — a synthetic hormone known as 17α-hydroxyprogesterone caproate (17-OHPC) — has been linked with an increased risk of cancer in offspring exposed to the treatment in the womb, says a new study. Read More
Biogen is investigating the death of a 75-year-old patient from cerebral edema that was possibly related to the antiamyloid antibody Aduhelm. Read More
More than 2,750 clinics in the U.S. offer a bewildering array of unauthorized stem cell types hawked for indications ranging from pain to erectile dysfunction to cures for COVID-19 to Alzheimer’s disease. Read More
The European Medicines Agency (EMA)’s safety committee said Johnson & Johnson’s (J&J) COVID-19 vaccine might be associated with cases of deep vein blood clotting — such as the leg, arm or groin — and recommended adding the rare side effect to the shot’s product information. Read More
Jacobus Pharmaceutical has recalled three lots of Ruzurgi (amifampridine) 10 mg tablets, which were found to be contaminated with yeast, mold and aerobic bacteria based on laboratory tests, the company said in a notice posted by the FDA. Read More
The FDA yesterday called for a revised Boxed Warning stating that Pfizer’s JAK inhibitors Xeljanz and Xeljanz XR (tofacitinib) — used to treat arthritis and ulcerative colitis — can cause an increased risk of serious heart-related events, cancer, blood clots and death. Read More