CDER approved 23 new drugs in the first half of 2017, topping the 22 approved in all 2016; there are at least 18 products in CDER's pipeline with a user fee date this year.
After exceeding its 2016 tally of new product approvals by June this year, the Center for Drug Evaluation and Research (CDER) could continue to build off its busy first half and approach record territories for 2017, as another large swath of applications are due for a decision over the next six months.
The US FDA approved Portola Pharmaceuticals Inc.'s blood thinner Bevyxxa (betrixaban) June 23, bring the novel drug approval total this year to 23, topping 2016's total of 22 less...
The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.
The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.
The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.
The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
