List view / Grid view
US Food and Drug Administration (FDA)
Filter the results
Compounded drug products are being voluntarily recalled due a lack of sterility assurance.
Ofev, which is under review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs), has been given Breakthrough Therapy Designation.
A jury has said that Johnson & Johnson must pay $8 billion in the case over male breast growth linked to Risperdal.
The FDA has approved the first treatment to increase pain-free light exposure in patients with the rare disorder, erythropoietic protoporphyria.
The FDA has given the designation to niraparib for the treatment of gene-mutated castration-resistant prostate cancer.
The FDA has announced its approval of Descovy, a PrEP method therapy, to reduce the risk of HIV-1 infection from sex.
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
The FDA has given a complete response letter to AstraZeneca for its PT010 treatment, regarding its New Drug Application.
Rituxan (rituximab) is the first approved treatment for children with rare vasculitis diseases, in which a patient’s small blood vessels become inflamed.
The drug daratumumab has been approved for treatment of multiple myeloma, demonstrating increased efficacy when used in combination with other drugs.
The FDA grants Orphan Drug Designation to treatments for rare diseases in R&D; here are the 10 most recent for oncologic conditions.
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
With the approval of the treatment, Rybelsus, there is a new option for treating type 2 diabetes without injections.