FDA

Biosimilars Have Entered the Market, But Are They Safe?Biosimilars are starting to come on the market, but some have questions about their safety.
Uro Pipeline: UTI vaccine receives fast track designation from FDAOther pipeline developments include an agent to control pain in IC/BPS patients, an antibody to treat prostate and bladder cancer, an injectable OAB treatment, and more.
Amneal Recalls 13 Lots of Lorazepam Oral
Amneal Recalls 13 Lots of Lorazepam OralThe provided droppers may have been mislabeled.
Pravastatin Bottles Recalled: Actual Content Is BupropionInternational Laboratories recalling one lot of bottles labeled 40-mg pravastatin.
Recall of Not-So-Sterile Drug ProductsFDA is alerting health professionals to a sterility breach with Vital Rx Inc. products.
FDA Recalls All PharmaTech Liquid Drugs
FDA Recalls All PharmaTech Liquid DrugsThe recall affects a variety of distributors.
The FDA Warns Against E-Cigarettes
The FDA Warns Against E-CigarettesA youth education campaign about e-cigarettes is part of FDA’s tobacco/nicotine plan.
Faster Drug Approvals Mean Healthier Patients (Maybe)
Faster Drug Approvals Mean Healthier Patients (Maybe)How the FDA is prioritizing drugs that offer the biggest health gains.
Controversy surrounds Exondys 51 approval: What to knowNew medicine for Duchenne muscular dystrophy raises questions. Here’s whose covering it and why.
FDA approves novel leukemia, hepatitis C drugsFDA approved the first treatment for patients with a certain type of acute myeloid leukemia, as well as 2 new drugs to treat hepatitis C.