“The requested CMC data outlined in the RTF letter are currently being generated, and we look forward to meeting with the FDA to align on next steps,” said Matt Pauls, Chair and Chief Executiv ...

The FDA has slapped Savara with a refuse to file (RTF) letter after the biotech in March applied for approval of molgramostim in the rare disease autoimmune pulmonary alveolar proteinosis (aPAP).

LANGHORNE, Pa., May 27, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that the ...

Savara Receives Refusal to File (RTF) Letter From the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for MOLBREEVI* to Treat Patients With Autoimmune Pulmonary ...

Roy Cooper said in a revised estimate report in December. In Thursday’s letter to Stein, FEMA official David Richardson gave no reason for the denial. Richardson said only that FEMA concluded ...

While the refusal letter generally provides a brief explanation, it often lacks the detailed context necessary to fully understand the decision. This is where the Global Case Management System ...

The letter alleged that Lively's lawyers demanded for Swift to "release a statement of support" for Lively in her ongoing case with Baldoni Gotham/GC Images; Matt Winkelmeyer/Getty; John Nacion ...

Travis Gettys is a senior editor for Raw Story based in northern Kentucky. He previously worked as a web editor for WLWT-TV and a contributing writer for the Kentucky Enquirer, and he also wrote ...

Eight faculty members in the physics department wrote an open letter on April 22 supporting a national statement by the American Association of Colleges and Universities (AAC&U) criticizing ...