Posts

The company was seeking approval of omburtamab to treat a rare form of nerve cancer in pediatric patients. The FDA’s decision follows a unanimous vote in October against the drug to treat neuroblastoma due to insufficient evidence that it improves overall survival.

The drug will be sold under the brand Rezlidhia and indicated for treating acute myeloid leukemia in patients with a susceptible genetic mutation.

The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea. In the United States, the infection is associated with 15,000-30,000 deaths annually.

Hemgenix is an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Regulators in Japan had previously denied emergency approval for the Shionogi pill, saying they wanted to see more data on its effectiveness. There were also concerns the drug could pose risk to pregnancies, based on results from animal studies.

​​​​​​​The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.

That means a 14-day regimen of the drug would translate to a price of $193,900, the company said on a conference call.

After examining the available information and hearing the testimony of CKD patients who participated in the clinical studies, the majority of the committee agreed the benefits of the medication outweighed its risks as a monotherapy.

Yesterday the U.S. health regulator issued an emergency use authorization to Roche’s test for the detection of DNA from monkeypox virus in swab specimens collected from people suspected of the virus infection.

Opioid overdose reversal drug naloxone may be safe and effective for over-the-counter use in some forms, the U.S. Food and Drug Administration said on Tuesday, potentially paving the way for its use federally.