Human Drugs
FDA Approves Genentechs Phesgo for Breast Cancer
FDA approves Genentechs outpatient breast cancer drug Phesgo.
Federal Register
Draft Guide on Anti-Infective Drug Products
Federal Register notice: FDA makes available a draft guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population.
Human Drugs
FDA Approves New Indication for Mercks Keytruda
FDA approves a new indication for Mercks Keytruda to treat specified forms of colorectal cancer.
Human Drugs
Anti-Infective Pediatric Drug Development Guidance
FDA publishes a draft guidance with general recommendations for sponsors developing anti-infective drug products for pediatric patients.
Biologics
FDA Stresses High Standards for Coronavirus Vaccine
FDA issues an immediately effective guidance for developers of Covid-19 vaccines saying any vaccine should be effective in at least 50% of those vacci...
Medical Devices
Avoid Hand Sanitizers with Methanol: FDA
FDA reiterates warning against hand sanitizers containing methanol.
Human Drugs
FDA Rejects Intercepts NASH Drug
Endpoint News reports that FDA has rejected an Intercept Pharmaceuticals NDA for its obeticholic acid to treat NASH.
Human Drugs
FDA Approves Rukobia for Some HIV Patients
FDA approves ViiVs Rukobia for certain HIV patients.
Federal Register
Comments Sought on Use Codeine for Analgesia
Federal Register notice: FDA establishes a docket to solicit public comment on specific questions pertaining to the use of codeine for analgesia in ch...
Human Drugs
Compounded Hormone Therapies Have Risks: National Academies
A National Academies committee says compounded bioidentical hormone therapies are insufficiently regulated and pose a public health risk.
