Merck won U.S. Food and Drug Administration approval for a first-of-its-kind oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor that is used to treat a rare genetic disease that causes benign and cancerous tumors in blood vessels associated with renal cell carcinoma.
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. Food and Drug Administration, which will speed up the regulatory process for these medications.
The U.S. Food and Drug Administration approved Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke.
The U.S. Food and Drug Administration authorized a third dose of Covid-19 vaccines by Pfizer-BioNTech and Moderna for people with compromised immune systems.
Drugmakers Pfizer, BioNTech and Moderna are expected to reap billions of dollars from Covid-19 booster shots in a market that could rival the $6 billion in annual sales for flu vaccines for years to come, analysts and healthcare investors say.
After discussions with the U.S. Food and Drug Administration, Paris-based Ipsen withdrew the company’s New Drug Application (NDA) for palovarotene.
The U.S. Food and Drug Administration approved Jazz Pharmaceuticals’ Xywav for idiopathic hypersomnia in adults.
The U.S. Food and Drug Administration placed a clinical hold on Boston-based Aprea Therapeutics’ lymphoid malignancy trial after the regulatory agency expressed concerns regarding the safety and efficacy data from a previous myelodysplastic syndromes (MDS) study.
The U.S. Food and Drug Administration is expected to announce that the regulatory agency is authorizing the use of a booster shot for the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines in some immunocompromised patients.
The U.S. Food and Drug Administration approved the combination of Merck’s anti-PD-1 therapy Keytruda plus Eisai’s orally available multiple receptor tyrosine kinase inhibitor Lenvima for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
