Drugmaker tried to shred records before FDA inspection, agency claims
(By Alia Paavola for Becker’s Hospital Review) FDA inspectors claim that Strides Pharma Science, an India-based drugmaker that sells numerous
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Patient dies from fecal transplant, FDA warns
(By Alia Paavola for Becker’s Hospital Review) The FDA alerted healthcare providers June 13 that at least one patient has died after
Read moreTeva expands nationwide recall of losartan
(By Alia Paavola for Becker’s Hospital Review) Teva Pharmaceuticals has recalled an additional six lots of bulk losartan potassium tablets,
Read moreFed up with Washington, ALS advocates consider ACT UP’s take-no-prisoners approach
(By Nicholas Florko for STAT) WASHINGTON — Next Wednesday, a cadre of ALS patients will gather for a protest outside
Read moreCancer Drugs Approved Quickly Often Fail To Measure Up Later
(By Richard Harris for NPR) Cancer drugs that speed onto the market based on encouraging preliminary studies often don’t show
Read moreHidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device
(By Christina Jewett for Kaiser Health News) Faced with the possibility that a bout of abnormal heartbeats could end his
Read moreMustang Bio’s brain cancer-targeting gene therapy granted FDA Orphan Drug designation
(By Andrea Park for Becker’s Hospital Review) A new gene therapy developed for the treatment of malignant glioma, a rare
Read more3 new AI-enabled FDA ‘Breakthrough Devices’: an Alzheimer’s-detecting retinal scanner, a kidney disease diagnostic & more
(By Andrea Park for Becker’s Hospital Review) Since the beginning of the month, the FDA has granted several artificial intelligence-powered
Read moreIn a crafty move, FDA may have found a way to dampen controversy over a $375,000 rare-disease drug
(By Ed Silverman for STAT) The Food and Drug Administration just added an unexpected twist to a simmering controversy over
Read moreFDA To End Program That Hid Millions Of Reports On Faulty Medical Devices
(By Christina Jewett for Kaiser Health News) The Food and Drug Administration announced it is shutting down its controversial “alternative
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