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Four months later, a committee of the FDA voted 8–5 against approval for rintatolimod, again citing insufficient data. [9] Work continues on the drug, and there has been no approval by the US FDA, as of May 2021. There is open-label use in the US, under Dr. Dan Peterson in Nevada. [10]
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
In December 2014, the Senate approved a bill that would add the Ebola virus to the Priority Review Voucher List. [23] The bill, S. 2917—Adding Ebola to the FDA Priority Review Voucher Program Act, was introduced by Senator Tom Harkin on November 12, 2014. President Obama signed it on December 16, and it became Public Law 113-233. [24]
In March 2024, the FDA approved amivantamab, in combination with carboplatin and pemetrexed, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. [11] The FDA also granted traditional approval to ...
Pfizer's shot, Prevnar 20, was approved in 2021 for use in adults aged 18 years or older and protects against 20 serotypes. It is also approved for use in six-weeks old infants to 17-year olds.
The FDA had given accelerated approval for Elahere in Nov. 2022, based on data from a single-arm trial in patients who had received at least one prior line of therapy that included Swiss-based ...
[7] However, in August 2022 Minerva submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for the approval of roluperidone for the treatment of schizophrenia. [8] The NDA submission in 2022 followed successful completion of a phase III clinical trial which was published in early 2022.
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.