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

XTalks

APRIL 15, 2025

Related: Orlynvah Approved for Uncomplicated UTIs After Initial FDA Rejection and Amid Concerns of Antimicrobial Resistance Antibiotics Revival After a Long Drought Blujepas approval marks the second of five regulatory milestones GSK aims to achieve this year.

FDA Approval 66

FDA Approval Bacteria DNA Bacterium 66

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

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 190

FDA Approval Protein Antibody Drugs 190

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.

FDA Approval 147

FDA Approval Antibody Clinical Trials Clinical Trials 147

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 184

FDA Approval Drugs Protein Antibody 184

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 162

FDA Approval Marketing Antibody Drugs 162

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 147

FDA Approval Vaccine Vaccination Antibody 147

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.

Antibody 115

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

XTalks

APRIL 9, 2025

Continued approval will depend on verification of clinical benefit from the ongoing ALIGN studys longterm analysis of estimated glomerular filtration rate decline. Beyond Vanrafia, Novartis is advancing zigakibart, a subcutaneously administered antiAPRIL monoclonal antibody in PhaseIII development for IgAN.

FDA Approval 59

FDA Approval Clinical Trials Clinical Trials Trials 59

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

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

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.

Antibody 130

Antibody Engineer FDA Approval Development 130

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 299

FDA Approval Licensing Licensing Antibody 299

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

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

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.

Allergies 66

Allergies FDA Approval Antibody Trials 66

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

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

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