XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

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XTalks

APRIL 9, 2025

XTALKS WEBINAR: Driving Efficiency and Quality in Clinical Trials Through AI & Innovation Live and On-Demand: Tuesday, May 27, 2025, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how AI is revolutionizing the efficiency and quality of clinical trials.

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Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As

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Pharmaceutical Technology

NOVEMBER 14, 2022

The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly. Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial.

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Antibody FDA Approval Clinical Trials Clinical Trials 246

Pharmaceutical Technology

MAY 25, 2023

Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval. The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

FDA Approval 264

FDA Approval Dermatology Sales Clinical Trials 264

Pharmaceutical Technology

JUNE 15, 2023

ALE.C04 is an investigational antibody designed to target exposed CLDN1 in cancer cells. This approval has been granted for ALE.C04 both as a monotherapy and in combination with pembrolizumab in a first-in-human clinical study in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

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FDA Approval Antibody Clinical Trials Clinical Trials 130

XTalks

APRIL 11, 2025

The FDA has approved Jobevne (bevacizumabnwgd) , a biosimilar to Avastin (bevacizumab). Jobevne, like Avastin, is a humanized monoclonal antibody that blocks vascular endothelial growth factor (VEGF). This marks BioconBiologics seventh biosimilar cleared for use in the US.

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XTalks

MARCH 10, 2025

The FDA has approved Celltrions Omlyclo (omalizumab-igec) as an interchangeable product to Xolair. Omlyclo marks Celltrions fourth FDA approval in barely three months this year a significant milestone signaling the companys rapid advancement in the biosimilar space.

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Allergies FDA Approval Antibody Trials 66

Pharmaceutical Technology

APRIL 17, 2023

Pharmaceutical company Genmab is entering a partnership with argenx to develop antibody therapies for oncology and immunology. This collaboration is being made to combine the companies’ capabilities to develop novel therapeutic antibodies with applications in the two disease areas.

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Antibody Engineer FDA Approval Development 130

XTalks

JULY 25, 2023

Cyfendus functions by stimulating the production of antibodies targeted against the protective antigen protein. These antibodies play a crucial role in providing protection by effectively neutralizing the cytotoxic lethal toxin and edema toxin of B. The recommended administration involves two doses, each of 0.5 Overall, 66.3

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FDA Approval Vaccination Vaccine Antibody 98

XTalks

MARCH 9, 2023

IgA nephropathy, also known as Berger’s disease , is a rare kidney disease that occurs due to build-up of the antibody immunoglobulin A in the kidneys. Results for this endpoint are expected in the final quarter of 2023 and are expected to support the traditional approval of Filspari. g/g and be at risk of rapid disease progression.

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Pharmaceutical Technology

OCTOBER 25, 2022

Based on positive data from the open-label, international, randomised, multicentre Phase III HIMALAYA clinical trial, the regulatory agency granted the approval. A human monoclonal antibody, Imfinzi attaches to the PD-L1 protein and hinders the PD-L1 interaction with the PD-1 and CD80 proteins.

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XTalks

MAY 26, 2022

The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. It is already approved for three other diseases, and EoE is the first gastrointestinal disease included in this group.

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FDA Approval Antibody Clinical Trials Clinical Trials 105

XTalks

JULY 14, 2022

Over time, even the use of Krystexxa can lead to the development of antibodies against it, reducing its effectiveness. Early data also showed that methotrexate could prevent the formation of anti-drug antibodies. XTALKS WEBINAR: Beyond the EHR: Clinical Trials in the Age of Abundant Data.

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FDA Approval Antibody Trials Drugs 105

XTalks

DECEMBER 10, 2021

Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor. CGRP receptor antagonists are a new class of antibody drugs used for migraine treatment. The trial has enrolled over 1,400 adult participants with a history of migraines.

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FDA Approval Trials Drugs Sales 98

XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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XTalks

OCTOBER 6, 2020

FDA approval for the treatment was based on results from the Phase III GO-VIVA clinical trial. Simponi Aria is a fully human anti-TNF-alpha monoclonal antibody that targets both the soluble and transmembrane bioactive forms of human TNF-alpha. The GO-VIVA Clinical Trial. Lovell, the Joseph E.

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FDA Approval Clinical Trials Clinical Trials Trials 71

XTalks

JANUARY 6, 2025

Just before the end of 2024, Novo Nordisk nabbed US Food and Drug Administration (FDA) approval for its awaited hemophilia drug Alhemo (concizumab-mtci). However, some patients develop inhibitors antibodies that neutralize the efficacy of replacement therapies. Hympavzi is administered once weekly.

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FDA Approval Antibody Drugs Clinical Trials 105

STAT News

DECEMBER 23, 2022

Food and Drug Administration approved a new treatment for patients with follicular lymphoma, a slow-growing type of blood cancer, said Genentech , its maker and a subsidiary of Roche. In a clinical trial, 60% of patients with follicular lymphoma treated with Lunsumio achieved a complete response.

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FDA Approval Immune Response Drugs Research 98

XTalks

OCTOBER 27, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv) for the treatment of relapsed or refractory multiple myeloma. Tecvayli is a first-in-class, bispecific T-cell engager antibody administered as a subcutaneous treatment.

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FDA Approval Antibody Drugs Trials 52

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. One year post-vaccination, antibody levels remained strong, with geometric mean titers well above the required protective threshold.

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Immune Response Vaccination Vaccine Trials 59

Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). Adopting staging classification criteria to better understand stages 1, 2, and 3 of T1D can help with overall therapy development and clinical trial design.

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Insulin FDA Approval Research Development 246

XTalks

JANUARY 21, 2022

For AbbVie’s Rinvoq, the FDA approval is an expansion of its approval for the treatment of rheumatoid arthritis and psoriatic arthritis. On the other hand, this is the first US approval for Cibinqo. Dupixent has been a market hit since it was first approved by the FDA in 2017.

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Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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FDA Approval Vaccination Vaccine Clinical Trials 102

Pharmaceutical Technology

OCTOBER 26, 2022

The treatment is indicated for such patients who had received four or more previous lines of therapy, including an immunomodulatory drug, proteasome inhibitor and anti-CD38 monoclonal antibody. Based on the response rate from a trial, the regulatory agency approved the indication under an accelerated approval process.

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Antibody FDA Approval Clinical Trials Clinical Trials 130

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

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XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN.

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Trials Clinical Trials Clinical Trials Antibody 101

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

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Pharma Mirror

FEBRUARY 11, 2021

KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS)

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XTalks

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis. Monoclonal antibody therapy has been found to have fewer side effects when compared to immunosuppressant drugs.

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Drug Delivery Systems Dermatology Drug Delivery Antibody 111

Pharmaceutical Technology

NOVEMBER 3, 2022

This approval has been granted for once-a-day 25mg tablets of Vemlidy for usage in paediatric patients aged 12 years and above with compensated liver disease. Trial 1092 met the primary endpoint of the percentage of subjects with HBV deoxyribonucleic acid (DNA) levels less than 20 IU/ml following 24 weeks of treatment.

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DNA FDA Approval Clinical Trials Clinical Trials 130

XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

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Trials Clinical Trials Clinical Trials Antibody 97

XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. Clinical trials have demonstrated the efficacy and safety of Susvimo in treating wet AMD.

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FDA Approval Clinical Trials Clinical Trials Sales 104

pharmaphorum

NOVEMBER 26, 2020

Y-mAbs Therapeutics has claimed its first product approval, getting a green light from the FDA for Danyelza for the rare cancer neuroblastoma. Both the antibodies stem from research carried out at the institution. Danyelza has been granted accelerated approval by the FDA on the strength of two open-label phase 2 studies.

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Drugs Antibody Clinical Trials Clinical Trials 106

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

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