The U.S. Food and Drug Administration on January 11 amended the fact sheet for Johnson & Johnson’s COVID-19 vaccine to include a rare risk of immune thrombocytopenia, a bleeding disorder.
Genentech’s Hemlibra (emicizumab-kxwh) showed no new safety signals and continued to deliver consistent bleeding control in the final analysis of a long-term, late-stage hemophilia A study.
Abbott’s Xience family of stents received U.S. Food and Drug Administration approval for one-month (as short as 28 days) dual anti-platelet therapy labeling for high bleeding risk patients in the United States.
The U.S. Food and Drug Administration granted approval to Myfembree, Myovant Sciences and Pfizer’s once-daily treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Patients receiving the therapy under the newly approved indication can take the medicine for up to 24 months.
Europe’s drug regulator is reviewing reports of rare blood clots in four people who received Johnson & Johnson’s Covid-19 vaccine and expanded its probe into AstraZeneca’s shot to include reports of a bleeding condition.
AbbVie won a first-of-its-kind approval for a non-surgical treatment aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
Medical supply company Baxter International agreed to buy Sanofi’s Seprafilm unit, which makes specialist surgical products, for $350 million in cash.
Shares in Solid Biosciences Inc. plunged 71 percent after a clinical trial testing the company’s gene therapy for a muscle-wasting disorder was halted for the second time in less than two years.
New data from TWILIGHT – a Phase IV independent trial funded by AstraZeneca – showed that in patients at high-bleeding risk who underwent PCI and completed three months of dual antiplatelet therapy, Brilinta monotherapy (90 mg twice daily) reduced the risk of BARC (Bleeding Academic Research Consortium) type 2, 3 or 5 bleeding compared to Brilinta plus low-dose aspirin after 12 months.
AbbVie announced the submission of a New Drug Application to the U.S. Food and Drug Administration for elagolix, an investigational GnRH antagonist for the management of heavy menstrual bleeding associated with uterine fibroids in women.