FDA
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
FEATURED STORIES
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
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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.
It’s a busy week for GlaxoSmithKline, although much of it is related to the upcoming demerger of its Consumer Healthcare business. Here’s a look.
The company said its Allergan eye drops met both its primary and key secondary endpoints, with patients reporting near and intermediate improvements in vision.