Phase 2
The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here’s a look at this week’s FDA activity.
Novartis’ canakinumab failed again in non-small cell lung cancer while Anixa Biosciences, Palisade Bio and Genexine kicked off new trials.
HHS found nearly half of NIH clinical trials were reported incorrectly, in violation of federal standards, according to a new report issued Friday by the agency.
The regulatory path for companies developing drugs for rare diseases is often fraught with challenges. KemPharm CEO Travis Mickle discussed just some of these with BioSpace.
Curis announced that the FDA has allowed patient enrollment to resume in the monotherapy phase of its TakeAim Leukemia Phase I/II trial studying emavusertib.
Ryvu and Opthea have new funding to work with, Tessa Therapeutics and Enlivex kick off new trials and Revive Therapeutics amends the Phase III protocol for its COVID-19 hopeful.
During the second quarter, NRx reactivated the development of NRX-101 and intends to initiate a Phase IIb/III study for ASIB by the end of this year or early 2023.
The U.K’s MHRA has granted conditional authorization to Moderna’s newest vaccine candidate, making it the first Omicron-specific COVID-19 booster vaccine approved by a regulatory agency.
This week holds moments of truth for Provention’s type 1 diabetes drug and bluebird bio’s gene therapy for beta-thalassemia. Amicus and Incyte are coming up at the end of the month.
AstraZeneca and Daiichi Sankyo’s Enhertu has been approved by the FDA as the first HER2-directed medicine for the treatment of patients with HER2-mutant metastatic NSCLC.
PRESS RELEASES