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Dr Stephen Hahn appointed as new FDA commissioner
Dr Stephen Hahn has been voted into the role of…
Dr Stephen Hahn has been voted into the role of FDA commissioner by the US Senate, taking over the role from Ned Sharpless.
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Ned Sharpless
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FDA proposes three solutions to mitigate drug shortages
The FDA has compiled a report which identifies the root…
The FDA has compiled a report which identifies the root causes of medicine shortages and suggests potential ways to alleviate scarcities.
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FDA sends warning letter to company illegally selling CBD products
A business selling unapproved products containing CBD has been sent…
A business selling unapproved products containing CBD has been sent a warning letter from the FDA and FTC for making unsubstantiated claims about their therapeutic properties.
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FDA approved 1,171 generic drugs in 2019
The FDA has released a statement on their generic drug…
The FDA has released a statement on their generic drug approvals in FY 2019, revealing a new record high breaking above last year.
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FDA and DEA send joint warning letters to illegal opioid sites
The FDA and DEA have, for the first time, sent…
The FDA and DEA have, for the first time, sent joint warning letters to four networks which were illegally selling opioid products.
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Sandoz voluntarily recalls ranitidine over NDMA contamination concerns
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules,…
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules, prompting the voluntary move.
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Federal judge enters consent decree against drug distributors
Two Tennessee companies have been prevented from distributing drugs after…
Two Tennessee companies have been prevented from distributing drugs after a complaint they were supplying unapproved medications.
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FDA grants Rozlytrek cancer treatment approval
The cancer therapeutic, Rozlytrek, has gained FDA approval as well…
The cancer therapeutic, Rozlytrek, has gained FDA approval as well as Priority Review, Breakthrough Therapy and Orphan Drug Designations.
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FDA approves first gene therapy for paediatric spinal muscular atrophy
The FDA has given approval to AveXis for the first…
The FDA has given approval to AveXis for the first treatment of paediatric spinal muscular atrophy (SMA).
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Acting FDA Commissioner named
As Dr Scott Gottlieb steps down from his role next…
As Dr Scott Gottlieb steps down from his role next month, Dr Ned Sharpless has been announced as his short-term replacement...
