pharma news
Mar 18, 2025
FDA Expands SOLIRIS for Pediatric Myasthenia Gravis; vTv’s Cadisegliatin Program Resumes as FDA Lifts Hold; ENCell’s EN001 Wins Orphan Drug Designation for Charcot-Marie-Tooth; FDA Accepts Sydnexis’ NDA for SYD-101 in Pediatric Myopia; Cambium Bio’s Potency Assay Strategy Cleared for Elate Ocular Phase III Trials
MDA Applauds FDA’s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis The Muscular Dystrophy Association (MDA) celebrates the FDA approval of an expanded indication for Alexion/AstraZeneca’s eculizumab (Soliris), now authorized for pediatric patients aged six and older with generalized myas...
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Mar 11, 2025
Neurotech’s ENCELTO Becomes First FDA-Approved Treatment for MacTel Type 2; Plus Therapeutics’ Rhenium Obisbemeda Gets FDA Orphan Status; Novo Nordisk Cuts WEGOVY to $499/Month; Capricor’s Deramiocel Wins FDA Priority Review; Celltrion’s OMLYCLO Becomes First Interchangeable XOLAIR Biosimilar
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
PRGN-2012 Wins Priority Review for Recurrent Respiratory Papillomatosis; PYX-201 Granted Fast Track for R/M HNSCC; AJA001 IND Cleared for Autism Spectrum Disorder; LAE120 IND Approved for Advanced Solid Tumors; Relacorilant NDA Accepted for Hypercortisolism Treatment
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
CTEXLI Approved for Cerebrotendinous Xanthomatosis; SIGX1094 Wins Fast Track for Diffuse Gastric Cancer; Bavarian Nordic’s Chikungunya Vaccine Cleared for Ages 12+; UX111 Gene Therapy Gains Priority Review for Sanfilippo Syndrome; SUBLOCADE Label Update Approved
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; 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 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 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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