Approvals
The FDA’s decision on Axsome Therapeutics’ Auvelity is based on positive results from a massive clinical program that covered over 1,100 patients with depression.
Daiichi Sankyo and AstraZeneca report another first-in-class approval for Enhertu, Bayer snags an sNDA in metastatic hormone-sensitive prostate cancer and Merck faces contamination challenges with Januvia.
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.
The FDA has had a busy week, accepting drug applications, approving clinical trials and granting various special designations for Gamida Cell, Cellectis, Scynexis & more.
FDA has approved GSK’s Benlysta (belimumab), making it the first biologic treatment for children ages 5 to 17 with lupus nephritis.
Ionis announced that the FDA has accepted its NDA for tofersen for SOD1-ALS. The application has been given the priority review designation and an action date of January 25, 2023.
The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.
Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted
FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.
Avadel and Jazz Pharma, a leader in treating sleep disorders, are locked in a patent dispute. If it receives final FDA approval, Avadel’s Lumryz could challenge Jazz’s market dominance.
PRESS RELEASES