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...
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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...
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Feb 25, 2025
FDA Approves CTEXLI, the First-Ever Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disorder Mirum Pharmaceuticals, Inc. announced that the FDA has approved CTEXLI (chenodiol) tablets as the first and only treatment for cerebrotendinous xanthomatosis (CTX), a rare, progressive, and debilitatin...
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Feb 18, 2025
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 11, 2025
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AstraZeneca Scraps £450M Vaccine Factory in UK, Dealing a Blow to Reeves AstraZeneca has withdrawn its planned £450 million investment to expand a vaccine manufacturing facility in Liverpool, citing reduced financial support from the new Labour government.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® (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 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 14, 2025
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 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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Discover How Learning Disability Treatment Landscape is Evolving with the Emergence of Digital Assistant Technologies
Jul 04, 2025
A New Era for Multiple Myeloma Treatment: Bispecific Antibodies Enter the Fray
Jun 10, 2025
LEQEMBI: A New Hope for Alzheimer’s Disease Patients
Feb 12, 2025
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