FDA
Feb 18, 2025
EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis; GSK’s Penmenvy Wins FDA Nod; Ono Pharmaceuticals’ ROMVIMZA Gets Green Light from FDA for Symptomatic TGCT; Bristol Myers Squibb Updates on RELATIVITY-098 Phase III Trial Findings; FDA Expands Label for Astellas’ IZERVAY in Geographic Atrophy Treatment
EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis Galderma has announced that the European Commission has approved NEMLUVIO in the European Union (EU) to treat both moderate-to-severe atopic dermatitis and prurigo nodularis. The approval allows Nemluvio to be used subcutaneously for pat...
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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AstraZeneca Scraps £450M Vaccine Factory in UK, Dealing a Blow to Reeves AstraZeneca has withdrawn its planned £450 million investment to expand a vaccine manufacturing facility in Liverpool, citing reduced financial support from the new Labour government.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 28, 2025
FDA Approves LEQEMBI IV Dosing for Early Alzheimer’s; Vanda Accepts FDA Hearing on Tradipitant for Gastroparesis; Cartesian Gains FDA Protocol Approval for Myasthenia Gravis Trial; Zai Lab Secures FDA Orphan Status for DLL3 ADC in SCLC; Dyne Receives FDA Fast Track for DYNE-101 in Myotonic Dystrophy
FDA Approves LEQEMBI® (Lecanemab-Irmb) IV Maintenance Dosing for Early Alzheimer’s Disease Treatment Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Supplemental Biologics License Application (sBLA) for LEQEMBI (lecanemab-irmb), allowing intravenous (IV) maintenance dosing every four week...
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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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Dec 31, 2024
Decoding Parkinson’s Diagnosis with Gene Therapies and Prevention Insights
Parkinson's disease is a progressive neurodegenerative disorder that affects nearly 10 million people worldwide. With the increasing prevalence of Parkinson's disease due to aging populations and environmental risk factors, this condition profoundly impacts motor functions, cognitive abilities, and overall quality ...
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