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Human Drugs

Reviewers Brief ODAC on Camizestrant Concerns

FDA medical reviewers ask the Oncologic Drugs Advisory Committee to consider their concerns about the benefit-risk assessment of AstraZenecas breast c...

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Biologics

Celgene Cell Therapy Facility Hit with Form 483

FDA cites significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including deficiencies in sterile p...

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Human Drugs

GSK NDA Accepted for Hepatitis B Drug

FDA accepts for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen.

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Federal Register

Insulet Class 1 Recall of Insulin Pump Components

Insulet recalls (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death.

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Human Drugs

8 Observations on Fujifilm Diosynth FDA-483

FDA releases the form FDA-483 with eight observations from an inspection at the Fujifilm Diosynth Biotechnologies Texas drug manufacturing facility in...

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Human Drugs

CGMP Violations at Lexia LLC

FDA warns Franklin, TN-based Lexia LLC about CGMP violations in its production of over-the-counter drugs and cosmetic products

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Human Drugs

Multiple Violations in Foshan Miwei Cosmetics Inspection

FDA warns Chinas Foshan Miwei Cosmetics Co. about CGMP violations in its production of three misbranded unapproved new over-the-counter drugs.

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Human Drugs

CGMP Issues at Intas Dehradun Unit

FDA warns Intas Pharmaceuticals Limited about CGMP violations in its production of finished drugs at the manufacturing facility in Selaqui, Dehradun, ...

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Human Drugs

J&J Imaavy sBLA for Rare Anemia Gets Priority Review

FDA accepts for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for warm autoimmune hemoly...

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Human Drugs

Tavneos Withdrawal Sought Over Data Manipulation, Safety Risks

FDA moves to increase pressure on Amgen to withdraw approval of autoimmune disease drug Tavneos (avacopan), concluding that the therapy lacks reliable...