Pharmaceutical Technology

NOVEMBER 18, 2022

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. The post US FDA approves Provention Bio’s Tzield to delay diabetes appeared first on Pharmaceutical Technology.

FDA Approval 246

FDA Approval Clinical Trials Clinical Trials Antibody 246

Pharmaceutical Technology

AUGUST 8, 2022

With the approval for this indication, AstraZeneca is entitled to make a milestone payment of $200m to Daiichi Sankyo under a partnership deal signed in 2019. A HER2-directed antibody-drug conjugate (ADC), Enhertu is co-developed and marketed by AstraZeneca and Daiichi Sankyo.

FDA Approval 265

FDA Approval HR Clinical Trials Clinical Trials 265

Bio Pharma Dive

DECEMBER 17, 2024

An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus.

FDA Approval 237

FDA Approval Antibody Drugs 237

Bio Pharma Dive

AUGUST 14, 2023

Elrexfio is the third bispecific antibody cleared to treat the blood cancer, and will compete with other therapies that target the “BCMA” protein on myeloma cells.

FDA Approval 246

FDA Approval Protein Antibody Drugs 246

Bio Pharma Dive

JULY 17, 2023

Developers AstraZeneca and Sanofi expect to make the preventive antibody treatment, called Beyfortus, available ahead of the upcoming cold season.

FDA Approval 237

FDA Approval Antibody Drugs Development 237

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 Licensing Licensing Antibody 245

Bio Pharma Dive

MAY 17, 2024

Imdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following chemotherapy in treating extensive-stage small cell lung cancer.

FDA Approval 193

FDA Approval Protein Antibody Drugs 193

Pharmaceutical Technology

JULY 31, 2023

US FDA and China’s NMPA have approved the Phase I trial of anti-GPRC5D/CD3 bispecific antibody (LBL-034) by Leads Biolabs.

Antibody 130

Antibody FDA Approval Trials 130

XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. to 4,437 yen, reflecting investor confidence.

Antibody 105

Antibody FDA Approval HR Trials 105

Bio Pharma Dive

JUNE 16, 2023

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

FDA Approval 187

FDA Approval Drugs Protein Antibody 187

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.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

Pharmaceutical Technology

FEBRUARY 19, 2024

An FDA approval in late 2024 would make it the first TROP2-directed therapy for NSCLC antibody drug conjugate patients.

Antibody 130

Antibody FDA Approval Drugs 130

Pharmaceutical Technology

SEPTEMBER 27, 2024

The US Food and Drug Administration (FDA) has announced the approval of Sanofi and Regeneron’s interleukin (IL)-4 and IL-13 monoclonal antibody, Dupixent, for the US market.

FDA Approval 163

FDA Approval Marketing Antibody Drugs 163

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.

FDA Approval 98

FDA Approval Antibody Development 98

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 148

FDA Approval Vaccine Vaccination Antibody 148

Pharmaceutical Technology

JULY 18, 2023

AstraZeneca’s Beyfortus becomes the first preventative option specifically designed for infants in their first RSV season.

FDA Approval 130

FDA Approval Antibody 130

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

Fierce Pharma

JULY 11, 2024

Following this month's FDA approval of Eli Lilly’s amyloid-busting antibody Kisunla (donanemab), the Alzheimer’s disease market is set to grow in earnest—and Lilly is already eyeing a spot at the t | On top of Eisai and Biogen's Leqembi, Kisunla’s approval likely marks the “end of the beginning in treating this disease,” Andrew Lechleiter, (..)

FDA Approval 111

FDA Approval Marketing Antibody 111

Pharmaceutical Technology

AUGUST 10, 2023

Janssen’s bispecific antibody received accelerated approval as a subcutaneous therapy based on Phase II trial data.

FDA Approval 130

FDA Approval Antibody Trials 130

Pharmaceutical Technology

AUGUST 21, 2023

The monoclonal antibody is the first to be approved for both adult and paediatric patients with CHAPLE disease.

FDA Approval 130

FDA Approval Antibody 130

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

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Antibody 130

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. It will be offered to patients in prefilled syringe and autoinjector administration options.

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

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.”

FDA Approval 122

FDA Approval Antibody Drugs Production 122

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 Protein Antibody Engineer 105

Pharmaceutical Technology

AUGUST 15, 2023

The FDA accelerated approval for the bispecific antibody is based on the results from a single-arm Phase II study in multiple myeloma.

FDA Approval 130

FDA Approval Antibody 130

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.

FDA Approval 97

FDA Approval Antibody Development 97

BioSpace

APRIL 8, 2024

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu is the first FDA-approved tumor-agnostic HER2-targeted therapy authorized for the treatment of solid tumors in adults who have undergone prior systemic treatment.

FDA Approval 85

FDA Approval Antibody Drugs 85

Pharmaceutical Technology

JUNE 15, 2023

Alentis Therapeutics has received US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application for ALE.C04 to treat Claudin-1 positive (CLDN1+) tumours. ALE.C04 is an investigational antibody designed to target exposed CLDN1 in cancer cells.

FDA Approval 130

FDA Approval Antibody Clinical Trials Clinical Trials 130

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.

Antibody 130

Antibody FDA Approval Branding Regulation 130

Bio Pharma Dive

AUGUST 4, 2023

The treatment, which won FDA approval in July, is expected to be available by the start of the typical RSV season this fall.

FDA Approval 130

FDA Approval Antibody 130

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 300

FDA Approval Licensing Licensing Antibody 300

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 Production Insulin Antibody 98

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.

Antibody 246

Antibody FDA Approval Clinical Trials Clinical Trials 246

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

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.

FDA Approval 105

FDA Approval Vaccine Vaccination Antibody 105

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

FDA Approval 98

FDA Approval Vaccine Vaccination Antibody 98

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 265

FDA Approval Licensing Licensing Antibody 265