The Food and Drug Administration has announced that it will fast-track the approval of a drug called selinexor sold under the brand name Xpovio for the treatment of a type of blood cancer called relapsed refractory multiple myeloma (RRMM). The approval will only be granted for certain adult patients who haven't responded well to other treatment options.
The Food and Drug Administration has alerted the public to a new recall from Medtronic concerning the maker's MiniMed insulin pumps. According to the company, some of these MiniMed pumps have a critical cybersecurity issue that cannot be patched, leaving them permanently vulnerable to hackers who wirelessly access them. These recalled pumps were sold in the United States and internationally.
The ongoing blood pressure medication recall has been expanded once again, the FDA announced this week. The expansion covers the hypertension drug losartan potassium, some batches of which were found to have unacceptably high levels of an impurity that may cause cancer in some patients. The latest expansion covers 32 batches of the tablets, but the FDA warns you shouldn't stop taking them.
The FDA has formally ended its controversial Alternative Summary Reporting (ASR) program, which provided some manufacturers with exemptions related to reporting individual medical device reports. With that program now scrapped, the FDA has also posted ASR data that was submitted to the agency from 1999 through 2019, enabling the public to download all of that information via 20 individual zip files.
The FDA is moving forward on plans to lower drug costs by streamlining the development and approval of generic medications, the agency said on Tuesday. A push for the faster development of generic alternatives to name-brand medication came from former FDA commissioner Dr. Scott Gottlieb, an effort that remains under acting commissioner Ned Sharpless.
Another high blood pressure drug is facing a recall over the discovery of unacceptably high levels of an impurity that may cause cancer in some patients, according to a new report. The warning about the impurity comes from the pharmacy Valisure, which informed the FDA last week about high levels of a substance called dimethylformamide, which is a common solvent used for chemical reactions.
The FDA has issued a new advisory that reveals one patient has died as a consequence of an investigational fecal microbiota transplant (FMT). Though the agency doesn't oppose these investigational studies into the potential benefits of FMTs, it warns that there are serious risks associated with undergoing the treatment, namely the transmission of bacteria that is resistant to a variety of drugs.
The FDA has announced that Teva Pharmaceuticals USA is expanding its voluntary recall of high blood pressure medication losartan potassium. The recall started on April 25 in the US, and has now been expanded to cover another six lots of bulk losartan potassium USP tablets. The recall is due to an impurity that may cause cancer in some high blood pressure patients.
US watchdogs are cracking down on vape liquid firms using social media influencers to push e-cigarette products, warning several brands over missing health disclaimers. The move comes after the US Food & Drug Administration (FDA) and Federal Trade Commission (FTC) announced they'd be going after companies pushing e-liquid products on kids, part of a crackdown in general on vaping.
The Food and Drug Administration (FDA) has issued its first approval for a gene therapy treatment targeting young children. The gene therapy is called Zolgensma, and it is designed to treat the rare genetic disease spinal muscular atrophy in children under the age of two. The FDA's Acting Commissioner Ned Sharpless called the approval a 'milestone' for gene therapy.
New, easier tests for two of the most common STIs have been cleared by the US FDA, paving the way for more rapid - and less uncomfortable - diagnosis and treatment. While tests for chlamydia and gonorrhea are already in widespread use, currently they can require relatively intrusive methods of sampling.
The Xvivo Perfusion System looks like a medical device out of a science fiction movie, but it's real and it was just granted FDA approval. The technology opens the door to a greater number of lung transplants by enabling teams to evaluate and potentially approve donor organs that would otherwise be discarded. The system was previously approved under a humanitarian device exemption, but that limited the number of patients who could benefit from the technology.