All Blogs
Jan 07, 2025
Chimerix Submits Dordaviprone NDA for Accelerated Approval in Recurrent H3 K27M-Mutant Diffuse Glioma to FDA; NMD Pharma’s NMD670 Receives FDA Orphan Drug Designation for Charcot-Marie-Tooth Disease; Verastem’s Avutometinib NDA Accepted for KRAS Mutant Ovarian Cancer; Capricor Submits BLA for Deramiocel in Duchenne Muscular Dystrophy; Axsome Completes Phase III Trial of AXS-05 for Alzheimer’s Agitation
Chimerix Submits Dordaviprone NDA for Accelerated Approval to FDA for Recurrent H3 K27M-Mutant Diffuse Glioma Chimerix announced the submission of a NDA to the FDA for dordaviprone. The application seeks accelerated approval for the treatment of recurrent H3 K27M-mutant diffuse glioma, a rare and aggressive brai...
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Jan 08, 2025
The Promise of Big Data in Healthcare: Transforming Treatment and Outcomes
In recent years, the healthcare sector has undergone a major transformation, thanks to the advent of Big Data. The term “Big Data” refers to vast amounts of data—structured and unstructured—that are generated at an incredible speed. This data, when harnessed correctly, has the potential to revolutionize healthcare ...
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Jan 10, 2025
The Rise of Molecular Glues: Transforming Protein-Protein Interactions into Therapeutic Opportunities
Molecular glues are a groundbreaking class of small molecules that are gaining significant attention in the field of drug discovery. These compounds offer a novel approach to modulating protein function, especially for challenging targets that have been difficult to address using traditional drug discovery methods....
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Jan 06, 2025
Lilly’s ZEPBOUND Clears Hurdle in Sleep Apnea Treatment
Eli Lilly’s blockbuster weight loss GLP-1 drug ZEPBOUND has received FDA approval to treat obstructive sleep apnea in adults with obesity, alongside diet and exercise. This marks the first FDA-approved medication for obstructive sleep apnea. The approval adds a second indication for ZEPBOUND, following its...
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Jan 03, 2025
7 Sickle Cell Disease Therapies to Keep an Eye on Post-Pfizer’s OXBRYTA Withdrawal
In September 2024, Pfizer voluntarily withdrew all lots of OXBRYTA for the treatment of SCD in all markets where it was approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanding access programs worldwide. The decision is based on the totality of clinical data, which now indicates tha...
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Jan 02, 2025
Genesis Medtech Secures Chinese Approval for Innovative 90° Articulating Stapler; Inogen Secures FDA 510(k) Clearance for SIMEOX 200 Airway Clearance Device; Microtech Unveils First Human Trial of Implantable Microsensor for Heart Failure Monitoring; NAVIGANTIS VASCO™ Platform Begins Clinical Role in Neurovascular Patient Study; Innovent Secures Global Rights from Roche for Novel DLL3 ADC in Exclusive Deal; Treace Expands Portfolio with Percuplasty
Genesis Medtech's World's First 90° Articulation Powered Stapler Achieved Chinese Approval On January 01, 2025, Genesis Medtech announced that iReach Omnia, the world's first powered stapler with 90° articulation capability, received market approval in China from the National Medical Products Administratio...
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Dec 31, 2024
FDA Approves Opdivo Qvantig™ for Solid Tumors; Nuvation Bio’s Taletrectinib NDA Accepted for ROS1-Positive NSCLC; HKBU’s Aptamer for X-Linked Hypophosphatemia Gets FDA Orphan Designation; Sapience’s ST316 Receives FDA Orphan Status for FAP; Precigen Submits BLA for PRGN-2012 in RRP
FDA Approves Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) for Subcutaneous Use in Adult Solid Tumors Bristol Myers Squibb has received FDA approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use. This innovative product is a combination of nivolumab and recombin...
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Dec 26, 2024
FDA Grants Approval to Merit Medical’s WRAPSODY Endoprosthesis; FDA Clears AVITA Medical’s Cohealyx, Expanding Treatment Potential; SeaStar Medical Launches 14th Location for Adult AKI Pivotal Study; Contego Medical’s Neuroguard IEP System Treats First Patients; SMT Introduces Hydra™ TAVI System in Russia; SandboxAQ Raises $300M+ to Accelerate AI’s Next Frontier
Merit Medical Announced FDA Approval of the WRAPSODY Cell-Impermeable Endoprosthesis On December 20, 2024, Merit Medical Systems, Inc., a leading global manufacturer and marketer of advanced healthcare technologies, announced that its WRAPSODY® Cell-Impermeable Endoprosthesis received premarket approval (P...
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Dec 24, 2024
FDA Approves Vertex’s ALYFTREK for Cystic Fibrosis; ZEPBOUND Gets FDA Approval for Obstructive Sleep Apnea in Obese Adults; Tonix’s TNX-102 SL NDA Accepted for Fibromyalgia; Quoin’s QRX003 Clears FDA for Netherton Syndrome Study; FDA Approves First Mesenchymal Stromal Cell Therapy for Acute GvHD
Vertex Receives US FDA Approval for ALYFTREK: A Breakthrough CFTR Modulator for Cystic Fibrosis Vertex Pharmaceuticals Incorporated announced that the FDA had approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily triple combination CFTR modulator for the treatment of cystic fibrosis. ALYFTREK is...
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Dec 30, 2024
6 Emerging Treg Cell-based Therapies Shaping the Future of Immunotherapy
Treg (regulatory T-cell) therapies utilize the immunosuppressive abilities of regulatory T-cells to address various conditions, such as autoimmune diseases, inflammatory disorders, and transplant rejection. These treatments take advantage of Tregs’ natural role in maintaining immune balance by suppressing overactiv...
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