FDA News

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (the “Company”) (Nasdaq: SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that it has received the Day 74 Letter from the FDA which indicated that an Advisory Committee meeting is not planned for the MOLBREEVI Biologics License Application (BLA) and the review is ongoing with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. Additionally, the Company recently submitt...

LEHI, Utah--(BUSINESS WIRE)--Owlet, Inc. (“Owlet” or the “Company”) (NYSE: OWLT), the pioneer of smart infant monitoring, today reports financial results for the fourth quarter and full year ended December 31, 2025. Owlet’s President and Chief Executive Officer, Jonathan Harris, and Chief Financial Officer, Amanda Twede Crawford, will host a conference call to review the Company’s results and provide a business update today, March 5, 2026, at 4:30 p.m. ET. Q4 2025 Financial Highlights: Q4 Reven...

GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced that it will report financial results for the fourth quarter and full year 2025 on Wednesday, March 18, 2026. Management will host a corresponding conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. A live audio webcast and an archiv...

ALBANY, N.Y. & SHANGHAI--(BUSINESS WIRE)--Drug Farm today announced that the U.S. Food and Drug Administration (U.S. Food and Drug Administration, FDA) has accepted DF-003, the company’s investigational therapy for ROSAH syndrome, into the FDA Rare Disease Evidence Principles Process (RDEP). The RDEP is an FDA initiative designed to facilitate early dialogue between the agency and sponsors developing therapies for rare diseases. Through the program, FDA works with selected sponsors to discuss r...

SYDNEY & BOSTON--(BUSINESS WIRE)--Harrison.ai today announced FDA 510(k) clearance for acute infarct triage on non-contrast CT Brain....

IRVINE, Calif.--(BUSINESS WIRE)--Immunis, Inc., a clinical-stage biotech company targeting age-related diseases, today announced it has entered an exclusive licensing agreement with Toray to develop and commercialize a drug candidate for the treatment of dyskinesia associated with Parkinson’s disease. Immunis will continue its development under the name “IMM02‑KORA” or “KORA.” Under the terms of the agreement, Immunis obtained exclusive rights to develop and commercialize “KORA” in the United S...

NASHVILLE, Tenn. & MENLO PARK, Calif.--(BUSINESS WIRE)--Mosaic Clinical Technologies™, a wholly-owned subsidiary of Radiology Partners, is pleased to announce that Cognita™, its AI business unit developing generative vision-language models (VLMs) for radiology, has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for Cognita Chest X-Ray (CXR)™1 across multiple critical indications. Cognita CXR is an industry-first generative vision-language model designed to assi...

BEDFORD, Mass. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, and Biogen Inc. (NASDAQ: BIIB), today announced the publication of data from studies of the investigational medicine zorevunersen in The New England Journal of Medicine (NEJM). The publication includes results from two completed Phase 1/2a and ongoing open-label extension (OLE) studies...

BOSTON--(BUSINESS WIRE)--PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies to treat severe neuromuscular and neurological diseases, today announced regulatory updates related to the FREEDOM2 trial. The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the FREEDOM2-DM1 Phase 2 multiple ascending dose (MAD), randomized, placebo-controlled clinical trial of PGN-EDODM1 in patients with myotonic d...

BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today reported financial results for the three months and full year ended December 31, 2025, and highlighted recent progress. “2025 was a transformative year for us, highlighted by the landmark FDA approval of AVMAPKI FAKZYNJA CO-PACK, the only medicine approved to specifically treat KRAS-mutated recurrent LGSOC. The launc...