Recent blog posts
The FDA approved updated packaging for Kite Pharma's Yescarta® with survival rate information
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The FDA approved updated packaging for Kite Pharma's Yescarta® with survival rate information
2 January 2024
The FDA has sanctioned an update to the packaging of Kite Pharma's Yescarta® treatment, now incorporating information on patient survival rates.
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WAINUA™ (eplontersen) Approved in US for Adult Polyneuropathy in Hereditary Transthyretin Amyloidosis
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WAINUA™ (eplontersen) Approved in US for Adult Polyneuropathy in Hereditary Transthyretin Amyloidosis
2 January 2024
WAINUA™ (eplontersen) Receives Groundbreaking US Sanction as a Treatment for Polyneuropathy in Adult Hereditary Transthyretin Amyloidosis Cases.
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Sanofi ends tusamitamab ravtansine Phase 3 trial for 2nd-line NSCLC due to unmet primary endpoint
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Sanofi ends tusamitamab ravtansine Phase 3 trial for 2nd-line NSCLC due to unmet primary endpoint
2 January 2024
Sanofi has terminated its study of tusamitamab ravtansine due to a Phase 3 trial in second-line NSCLC failing to achieve its main goal.
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GSK has secured an exclusive licensing deal with Hansoh Pharmaceutical for the compound HS-20093
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GSK has secured an exclusive licensing deal with Hansoh Pharmaceutical for the compound HS-20093
2 January 2024
GSK plc has entered an exclusive partnership with Hansoh Pharma to co-develop and market HS-20093, an antibody-drug conjugate (ADC) targeting B7-H3 with a clinically proven topoisomerase inhibitor payload for serious medical conditions.
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Aurinia Pharmaceuticals has formally submitted an IND application for its drug candidate AUR 200 to the FDA
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Aurinia Pharmaceuticals has formally submitted an IND application for its drug candidate AUR 200 to the FDA
29 December 2023
Aurinia Pharmaceuticals Inc. announced it filed an IND application for AUR200 with the FDA to advance its development.
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Merck Announces an Update on the U.S. Regulation Process for Gefapixant
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Merck Announces an Update on the U.S. Regulation Process for Gefapixant
29 December 2023
Merck announced it got an FDA Complete Response Letter regarding its New Drug Application for gefapixant.
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Rallybio Reveals Early Data from Phase 1 Escalating Dose Trial for RLYB116, a Novel Subcutaneous Complement 5 Blocker
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Rallybio Reveals Early Data from Phase 1 Escalating Dose Trial for RLYB116, a Novel Subcutaneous Complement 5 Blocker
29 December 2023
Rallybio Corporation revealed early Phase 1 trial results for RLYB116, a novel drug with prolonged action and subcutaneous administration in low volumes.
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Almirall Launches Initial Stage Clinical Trial for ALM223, a Modified IL-2 Fusion Protein to Treat Autoimmune Conditions
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Almirall Launches Initial Stage Clinical Trial for ALM223, a Modified IL-2 Fusion Protein to Treat Autoimmune Conditions
29 December 2023
Almirall S.A. has recently launched a phase I clinical trial to assess the safety profile, pharmacokinetic properties, immunogenic potential, and pharmacodynamic effects of ALM223.
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First participant receives dose in Tiziana Biotech's early-stage trial for nasal administered Foralumab targeting MS
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First participant receives dose in Tiziana Biotech's early-stage trial for nasal administered Foralumab targeting MS
29 December 2023
Tiziana Life Sciences Ltd. has announced the start of a Phase 2a trial, assessing the efficacy and safety of two doses of intranasal foralumab compared to placebo in patients with non-active secondary-progressive multiple sclerosis.
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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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