US Food and Drug Administrattion (FDA)

news

J&J’s Tremfya secures two paediatric psoriasis approvals from FDA

30 September 2025 | By Catherine Eckford (European Pharmaceutical Review)

The US FDA approvals make the drug the first IL-23 inhibitor to be licensed for two common skin conditions.

news

FDA announces drug product recall due to lack of sterility assurance

21 January 2020 | By Rachael Harper (European Pharmaceutical Review)

FUSION IV Pharmaceuticals, Inc dba AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products to the user level as they do not adhere to federal guidelines.

news

FDA approves sNDA for candidiasis treatment in paediatric patients

9 January 2020 | By Rachael Harper (European Pharmaceutical Review)

Supplemental new drug application (sNDA) has been approved for an expanded indication of MYCAMINE® for the treatment of invasive candidiasis in paediatric patients under four months old.

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FDA issues warning letter for misrepresentation of drug in advertisement

12 December 2019 | By Hannah Balfour (European Pharmaceutical Review)

Alkermes, Inc. have received the warning letter after a promotional material review found it failed to adequately represent the risks of using the drug Vivitrol for patients with opioid use disorder.