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 98

FDA Approval Antibody Development 98

Pharmaceutical Technology

AUGUST 12, 2022

A specifically engineered HER2-directed antibody drug conjugate (ADC), Enhertu is being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca. Enhertu is claimed to be the first HER2-directed therapy to receive approval for treating HER2 mutant metastatic NSCLC patients. “We In the trial, 1.9%

FDA Approval 264

FDA Approval Clinical Trials Clinical Trials Engineer 264

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

Bio Pharma Dive

SEPTEMBER 11, 2023

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

FDA Approval 312

FDA Approval Drugs Antibody 312

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

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

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 123

FDA Approval Marketing Antibody 123

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 183

FDA Approval Protein Antibody Drugs 183

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 86

FDA Approval Antibody Drugs 86

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 264

FDA Approval HR Clinical Trials Clinical Trials 264

pharmaphorum

OCTOBER 13, 2024

Pfizer’s anti-TFPI antibody marstacimab has been approved by the FDA to treat haemophilia, becoming the pharma group’s second new therapy for the blood disorder this year.Marstacimab will be launched as Hympavzi to treat haemophilia A without factor VIII inhibitors and haemophilia B without factor IX inhibitors in patients aged 12 and older and is (..)

FDA Approval 111

FDA Approval Antibody Drugs 111

BioPharma Reporter

JUNE 20, 2024

Biotest, a subsidiary of Grifols, has received FDA approval for Yimmugo, a treatment for primary antibody deficiency syndromes (PID)

FDA Approval 52

FDA Approval Antibody Regulation Marketing 52

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 110

Antibody FDA Approval Pharma Companies Drugs 110

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 353

FDA Approval Antibody Vaccination Vaccine 353

BioSpace

AUGUST 17, 2023

The regulator’s greenlight on Friday for Regeneron Pharmaceuticals’ monoclonal antibody Veopoz (pozelimab-bbfg) makes it the first and only treatment indicated for children and adults with CHAPLE disease.

Antibody 80

Antibody FDA Approval 80

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 285

FDA Approval Drugs Antibody Medicine 285

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

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

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

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

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 177

FDA Approval Drugs Protein Antibody 177

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

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

Fierce Pharma

AUGUST 10, 2023

Johnson & Johnson is digging its multiple myeloma moat deeper thanks to FDA approval for another novel drug. The FDA has signed off on the company's Talvey, a first-in-class bispecific antibody targeting GPRC5D. Johnson & Johnson is digging its multiple myeloma moat deeper.

FDA Approval 95

FDA Approval Antibody Drugs 95

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.

Antibody 69

Antibody FDA Approval Regulation Development 69

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 Protein Antibody Engineer 105

Pharmaceutical Commerce

FEBRUARY 21, 2024

Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.

FDA Approval 52

FDA Approval Antibody 52

BioPharma Reporter

SEPTEMBER 17, 2024

The original concerns of the US regulatory agency over the manufacturing of Eli Lillyâs Ebglyss seem to have been resolved, as the FDA greenlit the antibody drug on Friday.

FDA Approval 98

FDA Approval Drugs Antibody Manufacturing 98

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.

FDA Approval 89

FDA Approval Drugs Licensing Licensing 89

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

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.

FDA Approval 52

FDA Approval Life Science Antibody Drugs 52

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

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 82

FDA Approval Vaccination Vaccine Antibody 82