All Blogs

Mar 13, 2025

Caristo Wins FDA Clearance for AI Solution to Prevent Heart Attacks Caristo Diagnostics, focused on transforming the diagnosis and treatment of cardiovascular disease, has announced that its CaRi-Plaque technology has received 510(k) clearance from the FDA. CaRi-Plaque is an AI-powered image analysis tool design...

Mar 14, 2025

The success of CAR-T therapies like Bristol-Myers Squibb/Bluebird bio’s ABECMA and Janssen’s CARVYKTI is reshaping treatment paradigms, challenging traditional options like stem cell transplants and proteasome inhibitors. The multiple myeloma market size in the US is responding rapidly from ~USD 15 billion, with in...

Mar 12, 2025

Obesity isn't just a personal struggle; it's a worldwide epidemic affecting over 1 billion people. This alarming statistic highlights an urgent need for effective interventions, as obesity dramatically raises the risk of life-threatening conditions like type 2 diabetes, heart disease, sleep apnea, and even certain ...

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 10, 2025

For nearly three decades, Genentech has been the sole provider of an approved medication for acute stroke treatment. On 03 March 2025, the Roche subsidiary expanded its stroke treatment portfolio with FDA approval for TNKase (tenecteplase).   TNKase (tenecteplase) is a thrombolytic, clot-dissolving tis...

Mar 07, 2025

On March 3, 2025, BeiGene secured another approval for its anti-PD-1 antibody, TEVIMBRA, as the FDA granted clearance for its use in combination with platinum-based chemotherapy as a first-line treatment for adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1....

Mar 06, 2025

ABANZA Received FDA 510(k) Clearance for WasherCap™ Mini Implantable Fixation Device, Advancing Soft Tissue Repair Solutions  On February 26, 2025, ABANZA, a leader in advanced soft tissue repair solutions announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its innovative...

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...

Mar 03, 2025

Ono Pharmaceuticals received FDA approval on 14 February 2025 for vimseltinib, a treatment for tenosynovial giant cell tumor (TGCT), which will be sold under the brand name ROMVIMZA. This approval positions Ono in direct competition with fellow Japanese pharmaceutical company Daiichi Sankyo in the TGCT market. ...