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FDA tells Acadia Pharmaceuticals that its ongoing review of a supplemental NDA for Nuplazid (pimavanserin), indicated for treating...[ Price : $8.95]
FDA issues a table with recommendations for medical device manufacturers to use in association with an earlier pandemic guidance o...[ Price : $8.95]
Sandoz asks the DC federal court to order FDA to set aside its award of new chemical entity status and exclusivity to Sanofi Genzy...[ Price : $8.95]
The Association for Accessible Medicines raises several concerns with an FDA final guidance on controlled correspondence related t...[ Price : $8.95]
FDA clears a Brain Scientific 510(k) for its NeuroCap device, an advanced electroencephalogram electrode array used to obtain rapi...[ Price : $8.95]
GlobalData says that positive results from two Jyseleca testicular safety studies could lead to FDA approval for an indication for...[ Price : $8.95]
FDA clears an Ultragenyx Pharmaceutical IND for UX053, an investigational mRNA therapy being evaluated for treating Glycogen Stora...[ Price : $8.95]
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applica...