FDA
Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
FEATURED STORIES
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The drug, created by Vaxart, has just completed its Phase I trial and had submitted an Investigational New Drug application to move forward.
Seventeen years after buying global rights, AstraZeneca is finally announcing a win for the lupus community with an FDA approval for Saphnelo.
The U.S. FDA is starting off August with a mix of PDUFA dates for acne products, seizure medications and a new manufacturing process for a non-opioid pain killer. Here’s a look.
The FDA has already given its go-ahead to use lumasiran to treat PH1 and lower the urinary oxalate levels in pediatric and adult patients under the brand name OXLUMO.
Shares of Ardelyx, Inc. have fallen nearly 13% in premarket trading after the U.S. FDA rejected the company’s chronic kidney disease drug, tenapanor.
As COVID-19 infections continue to increase in the U.S., the FDA has expanded the EUA for Eli Lilly’s monoclonal antibody to include treatment with or without remdesivir.
Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.
Several biotech and biopharmaceutical companies have announced new wins with the U.S. Food and Drug Administration (FDA), with these wins ranging from Investigational New Drug (IND) application approvals for cancer treatment candidates to Fast Track Designations for investigational agents aimed toward opioid use disorder (OUD).
Merck’s Keytruda won FDA approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer. The approval marked the 30th for Keytruda.
Bristol Myers Squibb (BMS) announced Friday its decision to withdraw from the U.S. market the indication for its immune checkpoint inhibitor Opdivo® (nivolumab) as monotherapy for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.