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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Pharmaceutical Technology

FEBRUARY 3, 2023

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Pharyngitis, arthralgia, and back pain are the most common adverse reactions of the antibody.

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FDA Approval Antibody Clinical Trials Clinical Trials 147

pharmaphorum

DECEMBER 19, 2023

Big pharma companies like Pfizer are making significant investments in antibody-drug conjugates, a promising class of therapies. This article explores the growing interest and recent developments, including FDA approvals and the potential impact on the pharmaceutical industry.

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Antibody FDA Approval Pharma Companies Drugs 115

BioPharma Reporter

JULY 4, 2024

Eli Lilly has finally achieved FDA approval for its monoclonal antibody Alzheimerâs therapy donanemab, bringing new competition to the field for Eisai and Biogen.

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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 US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.

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XTalks

APRIL 9, 2025

Beyond Vanrafia, Novartis is advancing zigakibart, a subcutaneously administered antiAPRIL monoclonal antibody in PhaseIII development for IgAN. Topline data from that analysis are anticipated in mid2026.

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FDA Approval Clinical Trials Clinical Trials Trials 59

pharmaphorum

DECEMBER 30, 2021

Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA approval of a second candidate. “We look forward to working with the FDA in their review of our teclistamab submission.”

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FDA Approval Antibody Drugs Production 122

BioPharma Reporter

OCTOBER 15, 2024

The approval of Hympavzi makes it the first treatment for both hemophilia A and B to be administered through a pre-filled pen or syringe.

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FDA Approval Antibody Development 97

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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XTalks

OCTOBER 22, 2021

Boehringer Ingelheim’s Cyltezo has become the second interchangeable biosimilar approved by the FDA, and the first approved interchangeable monoclonal antibody. In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes.

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BioPharma Reporter

OCTOBER 15, 2020

Food and Drug Administration (FDA) has approved Regeneronâs Inmazeb for treatment of Ebola. The antibody cocktail was developed using the same ârapid responseâ technologies as Regeneronâs investigational COVID-19 antibody combination.

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FDA Approval Antibody Development Drugs 105

XTalks

JULY 25, 2023

“The approval of Cyfendus vaccine is symbolic of Emergent’s longstanding partnership with the US government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development, in the company’s press release. What Is Anthrax? How Does Cyfendus Work?

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FDA Approval Vaccination Vaccine Antibody 98

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Premarket Approval (PMA) process (CBER). Regulatory Considerations for Biologics. BLA process (CBER). NDA process (CBER).

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Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Q32 will also receive tiered royalty payments on net sales.

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XTalks

JULY 14, 2022

Uncontrolled gout is defined as gout that is unmanageable and/or develops resistance to conventional therapies. 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.

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FDA Approval Antibody Trials Drugs 105

XTalks

OCTOBER 16, 2024

Imuldosa’s approval followed a rigorous review process by the FDA. Dong-A ST, in collaboration with Meiji Seika Pharma, initially began developing the drug in 2013. The rights were transferred to Dong-A ST for further development in 2020.

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XTalks

JANUARY 29, 2025

Related: Eli Lillys Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi Leqembi was first approved in 2023 as a monoclonal antibody targeting amyloid-beta protofibrils and plaques proteins that cause brain cell damage and cognitive decline in Alzheimers disease.

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FDA Approval Sales Antibody Protein 66

BioSpace

JULY 16, 2023

regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.

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Antibody FDA Approval Regulation Development 68

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

OCTOBER 22, 2024

Astellas Pharma has won approval from the US Food and Drug Administration (FDA) for Vyloy (zolbetuximab) as a first-line treatment for adults with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Vyloy is a first-in-class monoclonal antibody that targets the CLDN18.2 targeting antibody-drug conjugate.

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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

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. The disease develops between the ages of 20 to 30 and progresses over time, often leading to end-stage kidney failure due to glomerular disease.

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FDA Approval Drugs Clinical Trials Clinical Trials 98

pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

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STAT News

NOVEMBER 14, 2022

The Food and Drug Administration on Monday approved a new treatment for patients with advanced ovarian cancer — an antibody that delivers a targeted dose of chemotherapy directly to cancer cells. The new drug, called Elahere, was developed by Immunogen, a biotech company based in Waltham, Mass.

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Medicine FDA Approval Antibody Drugs 98

XTalks

MAY 25, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab’s Epkinly (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two or more lines of systemic therapy.

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Antibody FDA Approval Drugs Trials 98

pharmaphorum

AUGUST 4, 2021

Istodax (romidepsin) – originally developed by Celgene – is the latest in a string of cancer drugs originally given accelerated approval based on mid-stage data to be withdrawn because a follow-up confirmatory trial missed the mark. .”

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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.

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FDA Approval Antibody Drugs Clinical Trials 105

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). Tzield’s approval brings the opportunity to explore how the drug can advance diabetes education, treatment, and management. “We

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Insulin FDA Approval Research Development 246

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

FEBRUARY 26, 2024

Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. Xolair is the first medication approved by the FDA to reduce allergic reactions to more than one type of food after accidental exposure.

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Allergies FDA Approval Drugs Protein 100

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 pain relief effects were sustained for up to 48 hours.

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FDA Approval Trials Drugs Sales 98

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. BTK plays an important role in the immune system by regulating B cell receptor signaling through its effects on the development and maturation of B cells.

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FDA Approval Life Science Clinical Trials Clinical Trials 97

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. Approval in Brazil would mark the vaccines first use in a region where chikungunya is widespread.

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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.

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FDA Approval Drugs Sales Trials 98

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.

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FDA Approval Clinical Trials Clinical Trials Trials 71

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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