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Marketing authorisation recommended to be withdrawn for preterm birth drug
A vote by an FDA committee has resulted in the suggestion that marketing authorisation is revoked for preterm birth treatment Makena.
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US Food and Drug Administration (FDA)
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Relapsing multiple sclerosis drug approved by FDA
VUMERITY has been granted approved by the FDA for the treatment of relapsing forms of multiple sclerosis based on data from a New Drug Application submission.
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FDA proposes three solutions to mitigate drug shortages
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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CAR-T cell therapy granted RMAT for relapsed/refractory multiple myeloma
An investigational CT053 CAR-T cell therapy for RRMM has been given Regenerative Medicine Advanced Therapy designation.
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Regulatory non-compliance business interruptions
Loss of manufacturing capability as a result of regulatory non-compliance can have a devastating impact on biopharma or medical device manufacturers. In this article, Jenny Yu shares real-life examples from the industry and highlights the downstream effects of these business interruptions.
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Mylan announces voluntary recall of Alprazolam tablets
Due to possible contamination from a foreign substance, Mylan Pharmaceuticals is voluntarily recalling one batch of its Alprazolam tablets.
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Quarter of new drugs approved by FDA publicly funded
A study has found that 25 percent of drugs with one or more new molecular entities approved by the FDA come from publicly funded research.
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FDA releases statement on reducing drug shortages
The FDA has announced its support of a drug manufacturer rating system that would allow purchasers to identify which have the most reliable supply, in an effort to reduce shortages.
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FDA announces update to NDMA testing recommendations
The FDA has released an additional NDMA testing method and has alerted the public to multiple voluntary recalls of ranitidine.
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FDA approves drug to prevent heart failure in type 2 diabetes patients
Farxiga, a treatment to reduce the risk of heart failure in patients with type 2 diabetes has been approved by the FDA.
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Early Alzheimer’s disease treatment meets trial primary endpoints
Aducanumab, an Alzheimer's disease treatment, will be submitted as part of a Biologics License Application after meeting clinical trial primary endpoints.
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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 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 approvals in FY 2019, revealing a new record high breaking above last year.
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Breakthrough therapy for cystic fibrosis approved by FDA
Trikafta is the first approved treatment that is effective for patients 12 years and older with the most common cystic fibrosis mutation.
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HER2-positive metastatic breast cancer treatment granted Priority Review
Priority Review has been granted for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of HER2-positive metastatic breast cancer.
