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FDA Authorizes ARTHEx for Early ATX-01 Trial in Myotonic Dystrophy under ArthemiR™
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FDA Authorizes ARTHEx for Early ATX-01 Trial in Myotonic Dystrophy under ArthemiR™
4 March 2024
FDA Grants ARTHEx Biotech Authorization to Start Early-Stage Clinical Study for ATX-01 in Treating Myotonic Dystrophy (DM1) under the ArthemiR™ Project.
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Ironwood Pharma Reports Positive Phase III Results for Apraglutide in Adult Short Bowel Syndrome
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Ironwood Pharma Reports Positive Phase III Results for Apraglutide in Adult Short Bowel Syndrome
4 March 2024
Ironwood Pharma reveals encouraging initial findings from an international Phase III study of Apraglutide, a weekly treatment for Short Bowel Syndrome leading to Intestinal Failure in adults.
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ImmPACT Bio Secures $8M CIRM Grant for Dual-Target CAR T Therapy Trial in Lupus
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ImmPACT Bio Secures $8M CIRM Grant for Dual-Target CAR T Therapy Trial in Lupus
4 March 2024
ImmPACT Bio Receives $8M from CIRM for Early-Stage Trial of Novel Dual-Target CAR T-Cell Treatment IMPT-514, Aimed at Tough-to-Treat Lupus Kidney Disease and Widespread Lupus Conditions.
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Preliminary Success for Janux Therapeutics’ Prostate and Solid Cancer Drugs JANX007 and JANX008
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Preliminary Success for Janux Therapeutics’ Prostate and Solid Cancer Drugs JANX007 and JANX008
29 February 2024
Janux Therapeutics Reports Promising Preliminary Results on Tolerability and Therapeutic Impact in Progressive Dose Studies for Prostate Cancer Therapy JANX007 and Solid Cancer Treatment JANX008.
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FDA Approves Alvotech-Teva's SIMLANDI®, New Biosimilar to Humira®
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FDA Approves Alvotech-Teva's SIMLANDI®, New Biosimilar to Humira®
29 February 2024
Alvotech and Teva have received FDA clearance for their product SIMLANDI® (adalimumab-ryvk), a novel substitutable biosimilar to Humira®.
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Encoded Therapeutics Gains UK Approval for ETX101 Gene Therapy Trial in Dravet Syndrome
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Encoded Therapeutics Gains UK Approval for ETX101 Gene Therapy Trial in Dravet Syndrome
29 February 2024
Encoded Therapeutics Receives UK Regulatory Nod for Experimental Gene Treatment ETX101 Aimed at Dravet Syndrome.
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Oscotec/Adel Begins Phase 1 Trial of ADEL-Y01 Anti-Tau Antibody for Alzheimer's
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Oscotec/Adel Begins Phase 1 Trial of ADEL-Y01 Anti-Tau Antibody for Alzheimer's
29 February 2024
Oscotec/Adel has commenced the initial human administration phase of their Phase 1 trial, testing the anti-tau antibody ADEL-Y01 as a potential treatment for Alzheimer's.
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U.S. and China Approve INDs for New EpCAM CAR-T Therapy Against Solid Tumors
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U.S. and China Approve INDs for New EpCAM CAR-T Therapy Against Solid Tumors
29 February 2024
Immunofoco Reveals U.S. and China Regulators Grant Green Light to IND Submissions for Novel EpCAM CAR-T Therapy Aimed at Treating Severe Solid Cancers.
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First Late-Stage Prostate Cancer Patient Dosed in OncoC4's BNT316/ONC-392 Study
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First Late-Stage Prostate Cancer Patient Dosed in OncoC4's BNT316/ONC-392 Study
29 February 2024
OncoC4 Reveals Initial Participant with Late-Stage Prostate Cancer Receives Dose in Early to Mid-Stage Study for BNT316/ONC-392, a Collaborative Effort with BioNTech.
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Absci Initiates Preclinical Trials for AI-Enhanced Anti-TL1A Candidate ABS-101
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Absci Initiates Preclinical Trials for AI-Enhanced Anti-TL1A Candidate ABS-101
29 February 2024
Absci Begins Preclinical Studies on ABS-101, a New Leading Candidate for an Anti-TL1A Antibody, Created and Enhanced with Advanced AI Design Tools.
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METTL1 tRNA Methyltransferase Inhibitors by STORM Therapeutics at ESMO
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METTL1 tRNA Methyltransferase Inhibitors by STORM Therapeutics at ESMO
29 February 2024
STORM Therapeutics will showcase research on its innovative METTL1 tRNA Methyltransferase blockers at the ESMO event for specialized cancer treatments.
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FDA Fast-Tracks Linvoseltamab Review for Relapsed/Refractory Multiple Myeloma
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FDA Fast-Tracks Linvoseltamab Review for Relapsed/Refractory Multiple Myeloma
29 February 2024
FDA hastens assessment of a new application for Linvoseltamab, aimed at treating recurring or resistant forms of Multiple Myeloma.
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