DelveInsight
Feb 12, 2025
Exploring the Current Alzheimer’s Disease Drug Development Pipeline
Alzheimer's disease continues to pose a significant challenge to global healthcare systems, with the 7MM reporting approximately 16 million diagnosed prevalent cases in 2023. This rising AD prevalence highlights an urgent need for innovative treatments to mitigate the growing disease burden on both patients and car...
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Feb 11, 2025
Immix Bio’s NXC-201 Gets FDA RMAT for AL Amyloidosis; Biodexa’s eRapa Wins Fast Track for Familial Adenomatous Polyposis; AbbVie’s EMBLAVEO Approved for Complicated Intra-Abdominal Infections; Insmed’s Brensocatib Gains Priority Review for Bronchiectasis; Aro Bio’s ABX1100 IND Cleared for Pompe Disease
Immix Biopharma's NXC-201 Receives FDA RMAT Designation for Relapsed/Refractory AL Amyloidosis Immix Biopharma has received the FDA’s RMAT (Regenerative Medicine Advanced Therapy) designation for NXC-201, a sterically optimized CAR-T therapy for relapsed/refractory AL amyloidosis. The designation is granted to r...
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Feb 04, 2025
AstraZeneca Scraps £450M UK Vaccine Factory; FDA Approves First Non-Opioid Pain Reliever JOURNAVX in 20+ Years; Axsome’s SYMBRAVO Wins FDA Nod for Migraine; March Biosciences’ MB-105 Gains FDA Orphan Status for T-Cell Lymphoma; Saol’s SL1009 NDA Accepted for Pyruvate Dehydrogenase Complex Deficiency
AstraZeneca Scraps £450M Vaccine Factory in UK, Dealing a Blow to Reeves AstraZeneca has withdrawn its planned £450 million investment to expand a vaccine manufacturing facility in Liverpool, citing reduced financial support from the new Labour government. Initially announced in the previous Conservative governm...
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Jan 22, 2025
Understanding the Acute Myeloid Leukemia Surge and the Road to Solutions
Acute Myeloid Leukemia (AML) represents a significant public health concern globally, with its prevalence and incidence on the rise. According to the American Cancer Society’s estimates for 2025, approximately 22K people in the United States are expected to be diagnosed with AML, with most cases occurring in adults...
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Jan 21, 2025
FDA Approves LUMAKRAS with VECTIBIX for KRAS G12C-Mutated Colorectal Cancer; PYC Receives FDA Rare Pediatric Disease Designation for VP-001; Novo Nordisk Links High-Dose WEGOVY to Increased Weight Loss; FDA Rejects Atara’s EBVALLO Due to Manufacturing Issues; Boehringer Faces Phase III Schizophrenia Fail and Legal Challenges
FDA Approves LUMAKRAS and VECTIBIX for KRAS G12C-Mutated Colorectal Cancer Amgen has secured FDA approval for LUMAKRAS (sotorasib) in combination with VECTIBIX (panitumumab) as a treatment for adults with KRAS G12C-mutated metastatic colorectal cancer (mCRC) who have previously received fluoropyrimidine-, oxalip...
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Jan 17, 2025
Everything You Need to Know About Acute Kidney Injury
Acute Kidney Injury (AKI) is a significant medical condition that affects millions of individuals worldwide each year. It is a rapidly progressive condition that requires timely diagnosis and treatment to prevent severe complications or long-term consequences. AKI is particularly prevalent in hospitalized patients,...
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Jan 16, 2025
Breakthrough Therapies Shaping the Future of Acute Kidney Injury Treatment
Acute kidney injury is a sudden and severe condition characterized by the rapid loss of kidney function, resulting in the accumulation of waste products in the blood and imbalances in fluids and electrolytes. It is often caused by factors such as severe dehydration, infections, certain medications, or complications...
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Jan 14, 2025
Agios’ PYRUKYND SNDA Accepted by FDA for Thalassemia; BridgeBio’s BBO-8520 Gets FDA Fast Track for KRASG12C-Mutated Lung Cancer; Nipocalimab Granted FDA Priority Review for Myasthenia Gravis; Rigel’s R289 Receives FDA Orphan Drug Designation for MDS; Rise Therapeutics Gets FDA IND Clearance for R-5780 in Cancer
FDA Accepts Agios’ SNDA for PYRUKYND in Thalassemia Patients Agios Pharmaceuticals, Inc. announced that the FDA has accepted its supplemental New Drug Application (sNDA) for PYRUKYND® (mitapivat) to treat adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The appl...
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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 06, 2025
Parkinson’s and Tuberculosis Share a Common Protein That Could Provide Better Drugs for Both
Parkinson's disease and tuberculosis are two significant health challenges that affect millions worldwide. Recent research has unveiled a fascinating connection between these two diseases through a common protein known as Parkin. Understanding this link not only sheds light on the mechanisms of both diseases but al...
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