Recent blog posts
Vericel Announces FDA Approval and Market Release of MACI Arthro
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Vericel Announces FDA Approval and Market Release of MACI Arthro
29 August 2024
This approval broadens the scope of the MACI® (autologous cultured chondrocytes on porcine collagen membrane) label.
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Roche's PiaSky receives EU approval as the first monthly subcutaneous therapy for PNH patients
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Roche's PiaSky receives EU approval as the first monthly subcutaneous therapy for PNH patients
29 August 2024
Roche has announced that the European Commission has granted approval for PiaSky® (crovalimab), an innovative recycling monoclonal antibody that targets the complement protein C5.
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Phase 1 study outcomes of exidavnemab published in The Journal of Clinical Pharmacology
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Phase 1 study outcomes of exidavnemab published in The Journal of Clinical Pharmacology
29 August 2024
BioArctic AB revealed the publication of the findings from two phase-1 trials involving exidavnemab(ABBV-0805) in The Journal of Clinical Pharmacology.
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SIFI Gains European Commission Nod for AKANTIOR®
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SIFI Gains European Commission Nod for AKANTIOR®
27 August 2024
SIFI revealed that the European Commission has granted approval for AKANTIOR® (polihexanide) for managing acanthamoeba keratitis (AK) in both adults and children aged 12 and over.
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EU Commission Approves Celltrion’s SteQeyma®, a Stelara® Biosimilar, for Chronic Inflammatory Disorders
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EU Commission Approves Celltrion’s SteQeyma®, a Stelara® Biosimilar, for Chronic Inflammatory Disorders
27 August 2024
The European Commission grants approval to Celltrion’s SteQeyma® (CT-P43), a biosimilar version of Stelara® (ustekinumab), for treating several chronic inflammatory disorders.
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FDA Approves Galapagos' IND for Phase 1/2 Trial of GLPG5101, a CD19 CAR-T Therapy
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FDA Approves Galapagos' IND for Phase 1/2 Trial of GLPG5101, a CD19 CAR-T Therapy
27 August 2024
Galapagos reveals FDA approval of its IND application for the Phase 1/2 ATALANTA-1 trial of CD19 CAR-T therapy, GLPG5101, in non-Hodgkin lymphoma that has relapsed or is refractory.
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Moderna Gains European Commission Nod for RSV Vaccine mRESVIA(R)
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Moderna Gains European Commission Nod for RSV Vaccine mRESVIA(R)
27 August 2024
Moderna, Inc. (NASDAQ:MRNA) reported that the European Commission (EC) has approved mRESVIA® (mRNA-1345), an mRNA vaccine targeting respiratory syncytial virus (RSV), for marketing.
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Mabwell Receives CDE Nod for New Nectin-4 ADC, Set to Start Phase III Cervical Cancer Trial
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Mabwell Receives CDE Nod for New Nectin-4 ADC, Set to Start Phase III Cervical Cancer Trial
27 August 2024
The company will commence a Phase III clinical trial aiming to investigate the effectiveness and safety of 9MW2821 in individuals with recurrent or metastatic cervical cancer (CC).
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YolTech Therapeutics Initiates Clinical Trial with First Dose of YOLT-203 for In Vivo Gene Editing in PH1 Therapy
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YolTech Therapeutics Initiates Clinical Trial with First Dose of YOLT-203 for In Vivo Gene Editing in PH1 Therapy
27 August 2024
YolTech Therapeutics Administers First Patient Dose of YOLT-203 in Clinical Trial for Groundbreaking In Vivo Gene Editing Therapy for PH1.
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Pfizer and BioNTech get U.S. FDA approval for Omicron KP.2-adapted COVID-19 vaccine
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Pfizer and BioNTech get U.S. FDA approval for Omicron KP.2-adapted COVID-19 vaccine
26 August 2024
FDA Approves Pfizer-BioNTech's Updated COVID-19 Vaccine for Ages 12 and Up; Grants Emergency Use for Ages 6 Months to 11 Years.
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European Commission Approves BALVERSA® (Erdafitinib) for Advanced Urothelial Cancer
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European Commission Approves BALVERSA® (Erdafitinib) for Advanced Urothelial Cancer
26 August 2024
The European Commission has granted approval for BALVERSA® (erdafitinib) in treating adults with advanced or metastatic urothelial cancer.
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iOmx Therapeutics Commences Phase Ib Trial Featuring OMX-0407
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iOmx Therapeutics Commences Phase Ib Trial Featuring OMX-0407
26 August 2024
This trial is investigating OMX-0407, a first-in-class, spectrum-selective SIK (salt-inducible kinase) inhibitor, in patients with advanced solid tumors.
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