Eagle Pharmaceuticals, Inc. has submitted a 505(b)(2) New Drug Application (NDA) to the FDA for its novel ready-to-use bivalirudin product...
Amneal Pharmaceuticals, Inc. announced the 505(b)(2) New Drug Application (NDA) approval from the FDA for Pemrydi RTU. This product is the first and only ready-to-use presentation of pemetrexed for injection and does not require reconstitution, dilution, or refrigeration.
Xeris Pharmaceuticals announced positive findings from a global Phase III trial of the Gvoke HypoPen, its ready-to-use (RTU) room-temperature stable...
Eagle Pharmaceuticals announced that it has received a Complete Response Letter from the FDA for its Kangio (bivalirudin injection), 505(b)(2)...