Serenity's SER120 should be held to the same efficacy standards as Ferring's Nocdurna, which the agency has declined to approve three times, citizen petition says.
Ferring Pharmaceuticals Inc. has turned to the US FDA's citizen petition process to keep Serenity Pharmaceuticals LLC from being the first to market with a desmopressin drug approved for nocturia.
In a Nov. 22 petition, Ferring requests FDA refrain from approving Serenity's new drug application (NDA) for SER120, a desmopressin nasal spray partnered with Allergan PLC., until...
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
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.
