Pharmaceutical Technology

MAY 16, 2023

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody directed against aggregated soluble (protofibril), as well as insoluble forms of Aβ. In January 2023, the US Food and Drug Administration (FDA) approved lecanemab under the accelerated approval pathway to treat AD.

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Antibody FDA Approval Drugs Trials 130

Pharmaceutical Technology

MARCH 23, 2023

The regulator granted approval for Zynyz’s Biologics License Application (BLA) under accelerated approval based on the duration of response (DOR) and tumour response rate. Zynyz (retifanlimab-dlwr) is a humanised monoclonal antibody targeting programmed death receptor-1 (PD-1).

FDA Approval 245

FDA Approval Antibody Trials Drugs 245

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 Drugs 130

Bio Pharma Dive

OCTOBER 14, 2020

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19.

Antibody 265

Antibody FDA Approval Drugs Research 265

Pharmaceutical Technology

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) for pregnant women during their third trimester to prevent pertussis (whooping cough) in newborn infants.

FDA Approval 147

FDA Approval Vaccination Vaccine Antibody 147

pharmaphorum

OCTOBER 4, 2022

The approval brings hope to many, with breast cancer having surpassed lung cancer to become the most commonly diagnosed cancer in the world: there are approximately 2.3 The post Roche gets FDA approval for HER2 breast cancer diagnostic appeared first on. HER2 is a receptor protein that accelerates cancer cell growth.

FDA Approval 105

FDA Approval Antibody Protein Drugs 105

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 Clinical Trials Clinical Trials 264

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.

FDA Approval 52

FDA Approval Antibody Drugs Clinical Trials 52

Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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Antibody Drugs FDA Approval Marketing 52

Bio Pharma Dive

SEPTEMBER 21, 2021

Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.

FDA Approval 297

FDA Approval Drugs Antibody Medicine 297

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 97

Bio Pharma Dive

SEPTEMBER 29, 2020

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.

FDA Approval 354

FDA Approval Antibody Vaccination Vaccine 354

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 efficacy data used for the FDA-approved label is based on post-hoc sensitivity analysis evaluating only the first 281 randomized patients in the trial.

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FDA Approval Drugs Clinical Trials Clinical Trials 98

Drug Discovery World

MAY 15, 2023

Certain advanced immunotherapies such as CAR T-Cell and bispecific antibody therapies suffer from high incidence of associated CRS. The post FDA approves study into CAR-T associated cytokine storm appeared first on Drug Discovery World (DDW).

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FDA Approval Clinical Trials Clinical Trials Antibody 52

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 Trials 122

XTalks

NOVEMBER 2, 2022

In this episode, Ayesha discussed the FDA approval of two new immunotherapies, including Janssen/Johnson & Johnson’s bispecific antibody Tecvayli for the treatment of relapsed or refractory multiple myeloma. The drug is the first bispecific T cell antibody to be approved in the US.

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FDA Approval Life Science Antibody Drugs 52

XTalks

NOVEMBER 16, 2022

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. The drug was approved under the FDA’s accelerated pathway and is indicated for adult patients with folate receptor alpha (FR?)-positive

FDA Approval 98

FDA Approval Antibody Drugs Protein 98

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.

FDA Approval 98

FDA Approval Antibody Insulin Drugs 98

XTalks

OCTOBER 25, 2022

Imjudo is an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) monoclonal antibody that blocks the action of CTLA-4. Related: AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer. Imjudo is administered as a single dose with Imfinzi, followed by Imfinzi infusions every four weeks.

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FDA Approval Drugs Trials Protein 98

XTalks

JUNE 8, 2022

Amgen’s Riabni, a CD20-directed cytolytic antibody and biosimilar to Rituxan, got approval from the FDA on Monday for adults with moderate to severe rheumatoid arthritis. B-cell targeted therapy with the monoclonal antibody Rituxan (rituximab) is used to treat RA. million Americans. Evidence for the Efficacy of Riabni.

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FDA Approval Antibody Clinical Trials Clinical Trials 92

Pharmaceutical Technology

APRIL 6, 2023

A recent wave of monoclonal antibodies, including the FDA-approved Eisai / Biogen ’s Leqembi (lecanemab), is expected to shake up the space. The difficulty in finding a treatment for Alzheimer’s disease has plagued the drug industry for decades.

FDA Approval 264

FDA Approval Antibody Drugs Trials 264

XTalks

JANUARY 6, 2023

Last week, the FDA approved a new infusible medication from TG Therapeutics for adults with relapsing forms of multiple sclerosis (MS), which include clinically isolated syndrome (CIS), relapsing-remitting (RR) MS, and active secondary progressive MS (SPMS). Briumvi (ublituximab-xiiy) Clinical Trial Results.

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FDA Approval Clinical Trials Clinical Trials Antibody 87

Drug Discovery World

APRIL 27, 2023

With the FDA approval of the humanised anti-CD3 mAb TZIELD (teplizumab-mzwv injection) and then its subsequent announced acquisition of Provention Bio by Sanofi for $2.9 We believed that having a fully human CD3 antibody may offer benefits to patients across many different chronic disease indications.”

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Antibody FDA Approval Development Life Science 52

Drug Discovery World

APRIL 6, 2023

Gohibic (vilobelimab) has been granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of Covid-19 in hospitalised adults. The post FDA approves Gohibic for emergency use in Covid-19 patients appeared first on Drug Discovery World (DDW).

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FDA Approval Antibody Trials Drugs 52

pharmaphorum

AUGUST 16, 2021

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The post Pfizer, BioNTech file for FDA approval of COVID booster shot appeared first on.

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FDA Approval Vaccination Vaccine Antibody 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. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults.

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FDA Approval Antibody Drugs Trials 105

Drug Discovery World

MARCH 1, 2023

Antiverse has successfully identified functional antibody clusters targeting two G-protein-coupled receptors (GPCRs), both displaying versatile binding profiles and nanomolar affinity. The company has raised $3 million in funding, which will enable in-house development of the antibodies showing the highest affinity blocking function.

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Antibody FDA Approval In-Vivo Development 52

The Pharma Data

OCTOBER 25, 2022

FDA Approves TECVAYLI ™( teclistamab- cqyv), the First Bispecific T- cell Engager Antibody for the Treatment of Cases with Regressed or Refractory Multiple Myeloma TECVAYLI ™, an off- the- shelf, subcutaneous remedy, is an important new drug for cases with incorrigible blood cancer who face limited treatment options. percent,95.7

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FDA Approval Antibody Drugs Medicine 75

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.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

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.

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Antibody 105

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Brukinsa is also indicated to treat adults with Mantle cell lymphoma, Waldenström’s macroglobulinemia and relapsed or refractory marginal zone lymphoma.

FDA Approval 96

FDA Approval Clinical Trials Clinical Trials Life Science 96

pharmaphorum

NOVEMBER 16, 2022

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. RxDx Assay – Roche’s immunohistochemistry (IHC) companion diagnostic for identifying ovarian patients eligible for ELAHERE – has been contemporaneously approved by the FDA.

FDA Approval 69

FDA Approval Protein Trials Drugs 69

BioTech 365

JANUARY 28, 2022

FDA Approves Genentech’s Vabysmo, the First Bispecific Antibody for the Eye, to Treat Two Leading Causes of Vision Loss FDA Approves Genentech’s Vabysmo, the First Bispecific Antibody for the Eye, to Treat Two Leading Causes of Vision Loss – Vabysmo … Continue reading →

FDA Approval 52

FDA Approval Antibody 52

Pharmaceutical Technology

FEBRUARY 5, 2023

Trodelvy has been approved for HR+/HER2- breast cancer adult patients who have previously received endocrine-based therapy and a minimum of two additional systemic therapies in the metastatic setting.

FDA Approval 264

FDA Approval Hormones Antibody HR 264

Pharmaceutical Technology

OCTOBER 7, 2022

Simultaneously, the companies have signed a securities purchase agreement under which Sanofi will procure $35m of Provention’s common stock on teplizumab, obtaining FDA approval. . An anti-CD3 monoclonal antibody, teplizumab is in the developmental stage to delay T1D.

FDA Approval 299

FDA Approval Antibody Drugs Medicine 299

Pharmaceutical Technology

MAY 12, 2023

In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year. The new monoclonal antibody fragment bentracimab is designed to reverse the antiplatelet activity of ticagrelor, a reversible oral P2Y12 platelet inhibitor.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Antibody 130

Drug Discovery World

NOVEMBER 21, 2022

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for anti-CD3-directed antibody TZIELD (teplizumab-mzwv), the first immunomodulatory treatment for type 1 diabetes (T1D). . The company also offers financial assistance options to eligible patients for out-of-pocket costs. . .

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FDA Approval Antibody Drugs Medicine 52