The FDA placed bluebird bio’s clinical trial for its candidate sickle cell disease (SCD) treatment on partial hold for participants under 18 years old.
ViiV Healthcare announced that the FDA approved Apretude, a long-acting injectable pre-exposure prophylactic option to reduce the risk of sexually acquired HIV-1.
The decision comes after the FDA granted the drug, Tezspire (tezepelumab), Priority Review status on positive results from the PATHFINDER clinical trial program.
After their latest trial delivered disappointing results, Pfizer and BioNTech are ready to test if a third dose of their COVID-19 vaccine would trigger an immune response in very young children.
Full results from the Phase III trial of Novavax’s proposed COVID-19 vaccine demonstrated the drug’s efficacy in preventing mild, moderate, and severe illness.
It is also a milestone for the immunoglobulin A nephropathy (IgAN) community, as TARPEYO becomes the first and only FDA-approved treatment to reduce proteinuria in this condition.
The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
The FDA said that it is not authorizing molnupiravir’s use during pregnancy as there are hardly any clinical scenarios where the benefits appear to outweigh the risks.
Cidara Therapeutics and Mundipharma today shared positive topline results from their Phase III trial on the use of rezafungin for candidemia and invasive candidiasis.
The collaboration covers the co-development and co-commercialization of products created from Foghorn’s BRM oncology program and another oncology target.
Novartis is going full steam ahead with its cancer development efforts, recently posting positive results from two ongoing trials for lymphoma and leukemia.
The following features are highlights from the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, held in-person in Atlanta, GA, and virtually from December 11 to 14.
A U.S. Congress subcommittee unanimously approved the ACT for ALS bill in a decision that could soon pour massive funding into the search for treatment for this debilitating and deadly disease.
