FDA
Enzyvant has resubmitted its Biologics Licensing Application to the U.S. FDA for its tissue-based regenerative pediatric congenital athymia therapy RVT-802.
FEATURED STORIES
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Swiss pharma giant Novartis has found itself at the center of a legal battle that could determine if the company engaged in a research project that was a kickback in disguise.
Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. Let us know which topics you want to hear more about.
Neos Therapeutics, Inc. announced that it has entered into a confidential settlement and licensing agreement with Teva Pharmaceuticals USA, Inc. to resolve all ongoing litigation involving Neos’ patents protecting its Cotempla XR-ODT® extended-release orally disintegrating tablets and Teva’s Abbreviated New Drug Application filed with the U.S. Food and Drug Administration to market a generic version of that product.
First and Only FDA-Approved Inhaled Levodopa for Intermittent Treatment of OFF Episodes in People with Parkinson’s Taking Carbidopa/Levodopa
The vaccine, Vaxelis, was approved to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenza type b.
As 2018 comes to a close, analysts, journalists, investors and industry-watchers are studying their crystal balls to see what trends to watch in the upcoming year. Here are 7 trends most likely to be hitting the news cycle.
After a delay in review, the FDA approved Acorda’s Inbrija for the intermittent treatment of OFF episodes of Parkinson’s.
Alexion Pharmaceuticals and Stemline Therapeutics both secured FDA approval for their drugs.
Bavarian Nordic A/S today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for the liquid-frozen version of the MVA-BN®for active immunization against smallpox in adults age 18 years and older.