Recent blog posts
NMPA Approves Review of Mabwell’s Injectable Drug 8MW0511 for Examination
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NMPA Approves Review of Mabwell’s Injectable Drug 8MW0511 for Examination
29 December 2023
Mabwell announced the NMPA's approval of its IND application for 8MW0511, an innovative injectable recombinant fusion protein drug.
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Telix has filed a licensing request for its biological product, TLX250-CDx, marketed as Zircaix™, aimed for use in renal cancer visualization
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Telix has filed a licensing request for its biological product, TLX250-CDx, marketed as Zircaix™, aimed for use in renal cancer visualization
28 December 2023
Telix Pharmaceuticals has submitted a BLA to the U.S. FDA for TLX250-CDx (Zircaix™), a PET scan diagnostic agent for clear cell renal cell carcinoma.
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Santhera's Vamorolone secures EU approval for Duchenne Muscular Dystrophy therapy
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Santhera's Vamorolone secures EU approval for Duchenne Muscular Dystrophy therapy
28 December 2023
Santhera Pharmaceuticals has declared that its drug, AGAMREE® (vamorolone), has received authorization within the European Union to be prescribed for those diagnosed with Duchenne muscular dystrophy.
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InnoCare Reveals Positive Outcome for Phase 2 Trial of TYK2 Blocker ICP-332 in Atomic Dermatitis Subjects, Achieving Main Goal
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InnoCare Reveals Positive Outcome for Phase 2 Trial of TYK2 Blocker ICP-332 in Atomic Dermatitis Subjects, Achieving Main Goal
28 December 2023
InnoCare Pharma has announced that their phase II trial of the novel TYK2 inhibitor ICP-332 met its primary endpoint in treating adults with moderate to severe atopic dermatitis.
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Caliway Secures Over $100M for Phase 3 Trial of Fat-Reduction Drug CBL-514
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Caliway Secures Over $100M for Phase 3 Trial of Fat-Reduction Drug CBL-514
28 December 2023
Caliway Finalizes Funding Round Exceeding Targets, Locks in Excess of $100M for Critical Phase 3 Trial of CBL-514 for Subcutaneous Fat Reduction.
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Wave Life Sciences initiates Phase 2 FORWARD-53 trial, treating Duchenne Muscular Dystrophy patients with WVE-N531
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Wave Life Sciences initiates Phase 2 FORWARD-53 trial, treating Duchenne Muscular Dystrophy patients with WVE-N531
28 December 2023
Wave Life Sciences has commenced the Phase 2 FORWARD-53 study, beginning treatment with WVE-N531 for individuals with Duchenne Muscular Dystrophy.
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LEO Pharma Inc. has confirmed that the FDA has endorsed Adbry® (tralokinumab-ldrm) to manage adolescents aged 12-17 with moderate to severe eczema
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LEO Pharma Inc. has confirmed that the FDA has endorsed Adbry® (tralokinumab-ldrm) to manage adolescents aged 12-17 with moderate to severe eczema
27 December 2023
LEO Pharma Inc. has disclosed that the FDA has recently broadened the sanctioned use of Adbry (tralokinumab-ldrm) by authorizing its application for young individuals.
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FDA approves PADCEV® and KEYTRUDA® combo treatment for advanced bladder cancer
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FDA approves PADCEV® and KEYTRUDA® combo treatment for advanced bladder cancer
27 December 2023
FDA greenlights the unique combination of enfortumab vedotin (PADCEV®) and pembrolizumab (KEYTRUDA®), marking the first coalescence of an ADC and PD-1 inhibitor to combat progressive bladder carcinoma.
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Cullinan Oncology begins Phase 1 trial of CLN-617, a novel biologic fusing IL-2 and IL-12 cytokines
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Cullinan Oncology begins Phase 1 trial of CLN-617, a novel biologic fusing IL-2 and IL-12 cytokines
27 December 2023
Cullinan Oncology has initiated a Phase 1 study of CLN-617, an innovative biologic that combines the properties of IL-2 and IL-12 cytokines
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FDA and EMA acknowledge submission for CSL's innovative Factor XIIa-blocking agent, Garadacimab
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FDA and EMA acknowledge submission for CSL's innovative Factor XIIa-blocking agent, Garadacimab
27 December 2023
CSL, a major biotech player, announced that the FDA has accepted its application for the once-monthly hereditary angioedema preventative drug, garadacimab (CSL312).
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Travere Therapeutics starts key Phase 3 trial of Pegtibatinase for Classical Homocystinuria (HCU) management
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Travere Therapeutics starts key Phase 3 trial of Pegtibatinase for Classical Homocystinuria (HCU) management
25 December 2023
Travere Therapeutics has begun a critical Phase 3 study of Pegtibatinase in the management of Classical Homocystinuria (HCU).
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Rezolute starts key Phase 3 trial for RZ358 to treat Congenital Hyperinsulinism
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Rezolute starts key Phase 3 trial for RZ358 to treat Congenital Hyperinsulinism
25 December 2023
Rezolute has commenced a pivotal Phase 3 clinical trial for its investigative drug, RZ358, aimed at treating patients with Congenital Hyperinsulinism.
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