FDA

Apr 08, 2025

Amgen’s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease Amgen announced that the FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a rare and chronic immune-mediated inflammatory condition that can affec...

Apr 01, 2025

Sanofi’s Qfitlia Becomes First US-Approved Therapy for Hemophilia A or B The FDA has approved Qfitlia (fitusiran), the first antithrombin-lowering therapy for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or hemophilia B patients (ages 12+) with or without inhibitors. Approval is bas...

Mar 26, 2025

Obesity is a chronic disease reaching alarming levels worldwide, leading to diabetes, cardiovascular disease, and metabolic disorders. It results from a mix of genetic, environmental, and lifestyle factors. Understanding what are the reasons for obesity—poor diet, inactivity, and hormonal imbalances—is crucial. Key...

Mar 25, 2025

Clover’s RSV Vaccine Candidate SCB-1019 Gains U.S. IND Clearance for Revaccination Study Clover Biopharmaceuticals, Ltd. has received FDA clearance for its Investigational New Drug (IND) application and has initiated a Phase I revaccination clinical trial for SCB-1019, its non-adjuvanted bivalent RSV prefusion-s...

Mar 18, 2025

MDA Applauds FDA’s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis The Muscular Dystrophy Association (MDA) celebrates the FDA approval of an expanded indication for Alexion/AstraZeneca’s eculizumab (Soliris), now authorized for pediatric patients aged six and older with generalized myas...

Mar 11, 2025

Neurotech’s ENCELTO Becomes First FDA-Approved Treatment for Macular Telangiectasia Type 2 Neurotech Pharmaceuticals, Inc. has announced that the FDA has approved ENCELTO (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel), a progressive neurodegenerative retinal disease th...

Mar 05, 2025

Major Depressive Disorder (MDD) is a widespread and debilitating psychiatric condition that continues to challenge patients, caregivers, and healthcare systems worldwide. Characterized by persistent sadness, loss of interest, cognitive dysfunction, and suicidal ideation, MDD remains a major public health concern. D...

Mar 04, 2025

FDA Grants Priority Review to Precigen’s BLA for PRGN-2012 in Recurrent Respiratory Papillomatosis Precigen, Inc. announced that the FDA has accepted its Biologics License Application (BLA) for PRGN-2012 (zopapogene imadenovec†), an investigational AdenoVerse gene therapy for adults with recurrent respiratory pa...

Feb 28, 2025

The Major Depressive Disorder drug treatment market is expanding rapidly due to the increasing demand for antidepressants and the disease’s profound impact on quality of life. In 2023, the major depressive disorder market across the 7MM was valued at an impressive USD 7.2 billion, and it’s poised for even greater e...

Feb 26, 2025

Alzheimer’s disease remains one of the most complex and devastating neurodegenerative disorders, affecting millions worldwide and placing an immense burden on patients, caregivers, and healthcare systems. Characterized by progressive cognitive decline, memory loss, and functional impairment, Alzheimer’s disease cur...