… data from troriluzole's new drug application (NDA) included: a 3-year real … . Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of VYGLXIA …

… . Food and Drug Administration (US FDA). The report pertains to the … -to-file controlled substance Abbreviated New Drug Application (ANDA). The company confirmed that the … EIR signifies that the US FDA has closed the inspection process …

… effectiveness for the NDA submission. The FDA agreed that Praxis’ … collaborative discussion with the FDA about opportunities to bring … acceptance of the ulixacaltamide NDA.” SCN2A- and SCN8A-DEEs … mortality. There are no FDA approved therapies. Off-label …

… Food and Drug Administration (FDA) aligning on key aspects … DLB) to support a potential New Drug Application (NDA) submission. There are currently … Regulatory Alignment Based on FDA feedback, CervoMed plans to … may receive from the FDA; the ability to implement …

… Efficacy Data in NMIBC FDA feedback supports 2 potential … in intermediate-risk NMIBC. FDA Feedback also confirms no … development path. Relmada secured FDA alignment on certain key … support a 505(b)(2) New Drug Application (NDA). “The positive outcome of …

… never formally approved by the FDA. “It was actually … safe and effective.” The FDA is now reevaluating products … grandfathered in without undergoing the New Drug Application process. “We need more … fluoride that came before the NDA process. “Your toothpaste, …

… Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for MK-6240 … disease radiodiaganostic.  The US FDA previously granted MK-6240 fast … MK-6240 NDA in 3Q 2025. The US FDA has set … are pleased the US FDA accepted our NDA for MK-6240,” …

… safety trial supporting the New Drug Application (NDA) review process of … Administration (FDA) as part of the NDA review for … of participation exceeds FDA’s request for cumulative … New Drug Application, submitted to the U.S. Food and Drug Administration (FDA …

… 286) receiving U.S. FDA ‘Fast Track’ designation … and anticipate filing its New Drug Application (NDA) in Q4 2025. … S., we received FDA approval and launched liraglutide … 9%) UZEDY             43     35   24% Anda             392     380   3% Other           …

… overall data submitted to FDA for review, including positive … regulatory pathway for the NDA filing for Cingal, statements … or new drug applications, including the PMA for Hyalofast and the NDA for … endpoints or because the FDA may determine that achievement …