After CRL in 2022, Pfizer and OPKO get FDA nod for pediatric growth hormone deficiency med
Pfizer and OPKO Health have finally cleared the regulatory hurdle at FDA for their once-weekly, long-acting growth hormone deficiency drug Ngenla, though Ascendis Pharma beat them with the approval of Skytrofa in August 2021.
The agency gave Ngenla a thumbs down in January of last year, with no reason cited by Pfizer. The duo, partners since 2014, had gotten the go-ahead in more than 40 other markets already.
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