Spinogenix Announces U.S. FDA Approval of its Investigational New Drug Application for its Phase 2a Clinical Trial of SPG601 for Fragile X Syndrome

SAN DIEGO, April 15, 2024 (GLOBE NEWSWIRE) -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class ... “The FDA approval of our U.S. IND for SPG601 for FXS ... Read More

FDA Expands Approval of Treatment for Generalized Pustular Psoriasis

According to a press release from the company, the FDA's approval ... states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients ... Read More

AbbVie’s New ‘Biological Missile’ Ovarian Cancer Treatment Gets Full FDA Approval

FILE - A sign for the U.S. Food and ... resistant to that treatment, requiring a new therapy like Elahere, AbbVie said in a press release. The FDA granted an accelerated approval to the drug ... Read More

Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

(“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin ... Read More

IntraBio Announces U.S. FDA Accepts New Drug Application for IB1001 for the Treatment of Niemann-Pick Disease Type C

IntraBio's IB1001 New Drug Application was accepted and granted priority review PDUFA date set for September 24th, 2024 Application based on positive results of the IB1001-301 Phase 3 Pivotal ... Read More

Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Osteosarcoma

today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Orphan Drug Designation (“ODD”) to LSTA1, the Company’s lead product candidate, for the treatment of ... Read More

Takeda Announces U.S. FDA Approval Of Supplemental New Drug Application (Snda) For ICLUSIG® (Ponatinib) In Adult Patient...

(BUSINESS WIRE )--Takeda (TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved ... approval was supported by data from the PhALLCON study – the first ... Read More

TELA Bio Announces U.S. Commercial Launch of LIQUIFIX™ – the Only FDA-Approved Liquid Adhesive for Internal Use in Hernia Surgery

The LIQUIFIX devices are the only FDA-approved devices that affix mesh and ... procedures performed each year in the United States (U.S.), the most common being inguinal hernia repair. Read More

Mesoblast gains as FDA backs regulatory plans for cell therapy

Mesoblast (NASDAQ:MESO) shares added ~22% premarket Tuesday after the Food & Drug Administration (FDA) indicated a favorable view on the company’s plans to win U.S. approval for its cell therapy ... Read More

Spinogenix Announces U.S. FDA Approval Of Its Investigational New Drug Application For Its Phase 2A Clinical Trial Of SPG601 For Fragile X Syndrome

“The FDA approval of our U.S. IND for SPG601 for ... and for that reason we are excited to launch our first U.S. trial to address this unmet need in FXS. The expansion of clinical programs ... Read More

Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Osteosarcoma

today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Orphan Drug Designation (“ODD”) to LSTA1, the Company’s ... Read More