according to the FDA. Novo’s GLP-1 drugs have been in shortage since 2022. The FDA said its decision was made after confirming with Novo that it had product availability and manufacturing capacity to meet curr
The FDA has removed automated external defibrillators (AEDs) from its device shortage list in an update this month, but added blood culturing systems. The agency also added six product codes to its discontinuance list. AEDs — both wearable AEDs (product code MVK) and non-wearable AEDs (prod...
FDA更新医疗器械短缺清单 - Deviceshortage list from FDA 2024年08月04日,FDA更新医疗器械缺货清单,表明清单内的医疗器械在美国市场出现严重缺货,FDA正在审评或将要提交审评的宝子们有望加快,以下为列入清单内的产品短缺产品 1、Blood Culturing 2、Oxygenator (Oxygenator,Long Term SupportGreater Than6Hours) FDA...
Antibiotic Injectable Coming Off FDA Shortage ListDa Hee HanPharmD
Usually, the end of a drug shortage is a good thing — signaling patient access and adequate supply of a much-needed medicine — and met without resistance. However, the demand for the compounded versions of GLP-1s puts FDA in a different, and unprecedented, place in evaluating what the en...
FDA Extends EpiPen Expiration Dates Amid Shortage More Rich Pedroncelli, File|AP The FDA added EpiPens to its list of drug shortages in May, citing manufacturing delays and supply disruptions. The Food and Drug Administration has extended the expiration date of some EpiPens ...
Infant Formula Market that was released in early 2023 in direct response to the February 2022 infant formula recall and the subsequent shortage of infant formula in the U.S. The FDA also partnered with the National Academies of Sciences, Engineering and Medicine, as directed by Congress, to ...
May 27, 2025, 09:00 ET AbelZeta Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for C-CAR168 for the Treatment of Refractory SLE, Including LN AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery ...
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.Sign up here. Nine years ago, I had my gallbladder removed. While I would never say I’m grateful for the many gallstones that invaded my college years, I am feeling somewhat relieved aft...
A Lilly spokesperson said anyone marketing or selling unapproved versions of tirzepatide, the chemical name for its weight-loss drug Zepbound and diabetes medicine Mounjaro, must now stop and begin transitioning patients to FDA-approved medicines. ...