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FDA extends by three months its review of an Optinose supplemental NDA for Xhance (fluticasone propionate) as a treatment for chro...[ Price : $8.95]
FDA publishes an interim policy delaying regulatory action on drug compounding using bulk drug substances while the agency develop...[ Price : $8.95]
FDA grants one provision in a Provepharm petition asking for restrictions on the approval of ANDAs or NDAs citing ProvayBlue as th...[ Price : $8.95]
FDA approves Novartis Fabhalta to treat adults with paroxysmal nocturnal hemoglobinuria.[ Price : $8.95]
Rep. Andy Harris calls for an investigation to determine whether an FDA cozy relationship with the drug industry led to a 10-year ...[ Price : $8.95]
Arcutis asks FDA to restrict approvals of any ANDA citing its Zoryve psoriasis cream as the reference-listed drug.[ Price : $8.95]
FDA opens its eSTAR electronic submission template for voluntary use for certain PMA submissions.[ Price : $8.95]
CBER director Peter Marks outlines his Centers plans to speed gene therapy development, such as through FDA-encouraged harmonizati...