fda

Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE (setmelanotide) for Patients as Young as 2 Years Old

BOSTON, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the…

2 days ago

AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market

New collagen-based dermal matrix designed for tissue generation, complementary to RECELL and PermeaDermCohealyx expected to triple AVITA Medical’s addressable market…

3 days ago

Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT(cosibelimab-ipdl)

WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food…

7 days ago

Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT(cosibelimab-ipdl)

WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food…

1 week ago

Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT(cosibelimab-ipdl)

WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food…

1 week ago

Theriva Biologics Announces U.S. FDA Guidance on Design of Phase 3 Study of VCN-01 for the Treatment of Metastatic Pancreatic Cancer

December 05, 2024 08:00 ET | Source: Theriva Biologics, Inc. ROCKVILLE, Md., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics…

2 weeks ago

CORRECTION: RadNets DeepHealth Subsidiary Expands FDA Clearance for SmartMammo Solution

November 29, 2024 09:43 ET | Source: RadNet, Inc. SmartMammo™’s AI algorithm now FDA cleared with GE HealthCare’s Senographe Pristina™,…

3 weeks ago

Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia

November 27, 2024 16:10 ET | Source: Applied Therapeutics NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc.…

4 weeks ago

Boehringer Ingelheim launches VETMEDIN Solution (pimobendan oral solution), first oral solution approved by the FDA for congestive heart failure in dogs

Heart disease in dogs is almost as common as it is in humans, affecting approximately 10 percent of dogs in…

4 weeks ago

IMUNON Announces Results from its End-of-Phase 2 Meeting with the FDA for its Lead IMNN-001 Clinical Program in Advanced Ovarian Cancer

FDA Project Team supports the company’s proposed Phase 3 trial strategy, including overall trial design, target patient population, treatment schedule,…

4 weeks ago