Medtronic receives FDA clearance for innovative Smart MDI system with Simplera CGM integration
Medtronic plc has received U.S. Food and Drug Administration (FDA) clearance for its innovative Smart Multiple Daily Injection (MDI) system, marking a new era in ... Read More
FDA accepts Bayer’s application to expand NUBEQA’s use in prostate cancer treatment
The U.S. Food and Drug Administration (FDA) has accepted Bayer’s supplemental new drug application (sNDA) for NUBEQA (darolutamide), potentially broadening its use for patients with ... Read More
Granules India gains key FDA approval for Unit V facility, marking major compliance milestone
Hyderabad-based Granules India Limited has achieved a significant regulatory milestone, securing an Establishment Inspection Report (EIR) with a “No Action Indicated” (NAI) status from the ... Read More
Ionis Pharmaceuticals moves forward with FDA review of donidalorsen for HAE
In a significant development for hereditary angioedema (HAE) patients, Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has accepted ... Read More
FDA approves Pfizer’s HYMPAVZI for breakthrough hemophilia treatment
In a major leap for hemophilia patients, Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted approval for HYMPAVZI ... Read More
Hurricane Helene wreaks havoc! Baxter’s largest facility shuts down, putting U.S. medical supply at risk
In an unexpected and devastating turn of events, Hurricane Helene has forced Baxter International Inc. to shut down its largest manufacturing facility in the United ... Read More
GE HealthCare receives FDA approval for Flyrcado PET radiotracer, set to transform coronary artery disease diagnosis
GE HealthCare has received the US Food and Drug Administration (FDA) approval for Flyrcado (flurpiridaz F-18), a breakthrough PET radiotracer poised to transform the diagnosis ... Read More
Organon to acquire Dermavant for $1.2bn, expanding its presence in immuno-dermatology
Organon, a global healthcare company focused on women’s health, has announced a definitive agreement to acquire Dermavant Sciences Ltd., a Roivant company specialising in immuno-dermatology, ... Read More
Theratechnologies faces critical disruption in EGRIFTA SV supply following FDA-induced factory shutdown
Theratechnologies Inc., a leading biopharmaceutical company based in Montreal, has announced a potentially significant disruption in the supply of its body fat reduction medication, EGRIFTA ... Read More
Athira Pharma stock nosedives after Alzheimer’s drug trial results disappoint
Athira Pharma's stock plunged by 75% after the company announced that its Phase 2/3 LIFT-AD clinical trial for its experimental Alzheimer’s drug, fosgonimeton, failed to ... Read More