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news.Genentech seeks approval for adult blindness drug
As part of the application, Genentech has requested a priority review designation from the FDA, which, if granted, would give the FDA six months from the agency’s receipt
As part of the application, Genentech has requested a priority review designation from the FDA, which, if granted, would give the FDA six months from the agency’s receipt
The FDA has requested additional information to address concerns over potential adverse events. Valeant says that it plans to meet with the FDA promptly to discuss the rejection
ADL5859 is a selective novel Delta agonist that has shown activity and an attractive safety profile in preclinical evaluation. The compound is under development for the potential relief
Bristol-Myers Squibb previously disclosed that it could take up to five years for the necessary studies to be completed to satisfy the FDA request. The companies have now
As remuneration for the inclusion of Japan into the VEGF trap collaboration, Regeneron will receive an upfront payment of $25 million, milestone payments related to potential approvals in
If approved, Mesavance would be the first available once-daily mesalamine treatment for active, mild-to-moderate ulcerative colitis. “The timely filing of our Mesavance NDA represents the fourth new product
The agreement in December 2003 established a collaboration to utilize molecular cytogenetics to identify and validate oncology targets. Avalon seeks to discover and develop novel therapeutics through the
The FDA assigns priority review status to medicines that may provide a significant therapeutic advance over existing therapies. Once the FDA formally determines the application is sufficiently complete
The novel formulation of citalopram hydrobromide (HBr) may offer physicians a new dosing option with potential benefits and prescribing flexibility that may be advantageous when addressing the needs
Sirna completed its preclinical evaluation of the efficacy of Sirna-AV34 and has begun manufacturing for its phase I clinical studies. Sirna will conduct toxicology studies in the first