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Success rates for Phase 1 are based on a 3-year rolling average (2020-2022); rates for Phase 2 and Phase 3/Registration represent a 5-year rolling average (2018-2022). First in Human (FIH) to approval median phase cycle times are based on 3-year rolling cohort for Phase 1 and 5-year rolling cohort for Phase 2 to Registration.
Pfizer can reach more patients with life-saving treatments, sooner. Since 2019, we’ve decreased our median first-in-human to approval development timeline for new medicines and vaccines from nine years to approximately five years in 2022.
Since 2019, we’ve decreased our median first-in-human to approval development timeline for new medicines and vaccines from nine years to approximately five years in 2022. We have ambitious goals to reduce timelines even further so we can get medicines to patients even faster.
8 lis 2023 · This study demonstrated which agilities impacted the regulatory review times in a pandemic scenario and showed that many of these agilities did lead to reduced review times for the COVID-19 vaccine as compared to the Pfizer standard approval times.
31 sty 2023 · In December 2022, Pfizer and BioNTech announced the FDA granted Emergency Use Authorization (EUA) of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose...
2 kwi 2022 · Pfizer paid “$2.8 million bribe payment” to the FDA for COVID-19 vaccine approval. The Prescription Drug User Fee Act was passed in 1992 and allows the FDA to collect fees from drug companies...
8 lut 2022 · Pfizer’s 2022 financial guidance is presented below. This guidance includes management’s expectations for contributions from the entire company, including Comirnaty (1) and Paxlovid.
