European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). 2007; 2(1):5-11. In August 2024, the European Commission approved EURneffy (adrenaline nasal spray) in the EU as the first needle-free emergency option to treat anaphylaxis. 2022 ; 17(11). Fitzcharles-Bowe C et al. Hand (N Y).

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

European Pharmaceutical Review

JULY 20, 2023

More recently, the FDA granted approval of Roctavian in June 2023. She stated that some of the key concerns were around viral safety, immunogenicity and the fact that long term side effects are unknown. This included the EC’s approval of Roctavian in August 2022, which was the first gene therapy for haemophilia A.

Consulting 74

Consulting Manufacturing Side effects Safety 74

Pharmaceutical Technology

AUGUST 17, 2008

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? In terms of concerns over safety, it has meant that the FDA has been essentially very cautious in moving forward.

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Food and Drug Administration Food FDA Safety 40