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 ...

“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 ...

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that the Company received an RTF letter from the FDA for ...

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 ...

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).

PARIS — Iga Swiatek said it’s unfair that the chair umpire refused her request to climb down and inspect a mark during her semifinal loss to top-ranked Aryna Sabalenka at the French Open on ...

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 ...

Paul Weller, Primal Scream and DJ Annie Mac are among the music stars who have signed a letter in support of rap group Kneecap. The politically-charged Belfast trio, who are no strangers to ...

The letter, released publicly on Wednesday, outlined seven priorities for the government to focus on. “Canada’s new government has an immense responsibility to address these challenges head on ...