By recent standards, the first quarter of 2024 has been relatively slow in terms of novel drug approvals. Only 10 new drugs were granted authorization in the first three months of the year (Tablel). This compares to 13 in the first quarter of 2023 -a figure that was equalled or best...
FDA is on track this year to authorize a notable number of new molecular entities and important biotech therapies.
A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)'s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics...
these compounds, or may choose to approve compounds not approved by the FDA. Our focus on drug approvals by the FDA does not imply any opinion on the scientific quality of approvals by the FDA as compared to the regulatory authorities in other jurisdictions, but rather uses the FDA as a ...
Insights+: The US FDA New Drug Approvals in October 2020The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (...
FDA. Advancing health through innovation: 2018 new drug therapy approvals https://www.fda.gov/media/120357/download (2019). Chen, E. Y., Joshi, S. K., Tran, A. & Prasad, V. Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical ...
FDA New Drug Approval Times,Prescription Drug User Fees and R&D Spending[OL].http://www.aei-brookings,org 2006.John A.Vernon,Joseph H.Golec,Randall Lutter,Clark Nardinelli.“FDA New Drug ApprovalTimes,Prescription Drug User Fees and R&D Spend-ing”.www.aei-brookings.org. 2006...
The second quarter of 2018 saw an uptick in drug approvals as 15 new drugs received a green light from the FDA ( Table 1 ), compared with 6 in the first quarter. Among the most notable of the new crop was GW Pharmaceuticals' cannabidiol (Epidiolex), the first cannabis-derived drug to...
With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approach...
For its part, the FDA suggests thatmany variables could lead to a high number of drug approvals, including the number of applications received the previous year, the quality of the applications submitted in 2017, and the characteristics of the new products resulting in opportunities to use...