pharma news
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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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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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 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 17, 2024
FDA Approves Neurocrine’s CRENESSITY for Congenital Adrenal Hyperplasia; Checkpoint’s UNLOXCYT Approved; MAIA’s THIO Gets Rare Pediatric Disease Designation; JEMPERLI Receives Breakthrough Therapy for Rectal Cancer; Galderma’s NEMLUVIO Approved for Atopic Dermatitis.
Neurocrine Announces FDA Approval of CRENESSITY for Congenital Adrenal Hyperplasia Neurocrine Biosciences, Inc. announced that the FDA has approved CRENESSITY™ (crinecerfont) as an adjunctive treatment to glucocorticoid replacement for controlling androgens in adult and pediatric patients aged four years and old...
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Dec 10, 2024
AbbVie Reveals Phase III TEMPO-2 Trial Positive Topline Results; FDA Accepts GSK’s NUCALA Submission in COPD; Novartis Boosts Huntington’s Disease Development Program with PTC518 In-Licensing; Chimerix to File for Accelerated FDA Approval of Dordaviprone for H3 K27M-Mutant Diffuse Glioma; MeiraGTx Receives FDA RMAT Designation for AAV2-hAQP1 in Grade 2/3 Radiation-Induced Xerostomia Treatment
AbbVie Unveils Positive Phase III TEMPO-2 Trial Findings for Tavapadon as Parkinson's Disease Monotherapy AbbVie announced favorable topline results from its pivotal Phase III TEMPO-2 trial, which assessed the investigational drug tavapadon as a flexible-dose monotherapy for early-stage Parkinson's disease. Tava...
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Dec 03, 2024
FDA Grants Fast Track for Lin BioScience’s LBS-007; Alnylam’s AMVUTTRA sNDA Under Review; FDA Approves RAPIBLYK for Atrial Fibrillation; Applied Therapeutics Receives CRL for Govorestat in Galactosemia; R289 Gets Fast Track for Lower-Risk MDS.
Lin BioScience Receives FDA Fast Track Designation for LBS-007 Lin BioScience, a clinical-stage biopharmaceutical company focused on developing innovative therapies for acute leukemia, announced that its lead pipeline candidate, LBS-007, has been granted Fast Track Designation by the FDA for the treatment of acu...
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Nov 26, 2024
FDA Grants Orphan Drug Designation for Ractigen’s RAG-21 in ALS; Intellia’s Nexiguran RMAT for ATTR Amyloidosis; FDA Approves Acoramidis for ATTR-CM; Jazz Wins FDA Approval for Ziihera in HER2-Positive Biliary Cancer; J&J Seeks FDA Approval for Subcutaneous TREMFYA in Colitis
Ractigen Therapeutics Receives FDA Orphan Drug Designation for RAG-21 to Treat ALS Ractigen Therapeutics has announced that the FDA has granted Orphan Drug Designation (ODD) to RAG-21, its novel siRNA therapy for treating amyotrophic lateral sclerosis (ALS). RAG-21 specifically targets FUS-ALS, one of the most a...
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