The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [i]

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

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). These therapies work by reprogramming the immune system, preventing it from attacking and eradicating insulin-producing cells in the pancreas. With up to 2.3

Insulin 246

Insulin FDA Approval Research Clinical Trials 246

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

AUGUST 17, 2020

Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. The design of the immune biologic puts these elements together on an antibody scaffold. Image from Cue Biopharma.

Protein 98

Protein Engineer Immune Response In-Vivo 98

XTalks

SEPTEMBER 17, 2020

Acromegaly Surrogate Endpoint: Serum growth hormone and serum insulin-like growth factor 1 (IGF-1) are acceptable surrogate endpoints for acromegaly clinical trials involving somatostatin analogs such as octreotide, lanreotide and pasireotide. Nizoral is prescribed off-label, while the others are FDA approved.

Trials 98

Trials Gene Hormones Clinical Trials 98

XTalks

JUNE 12, 2023

Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor. Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. These approvals reinforced the company’s position as a global leader in eye health. billion ($22.83 billion USD), a 20.65

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

Drug Discovery World

JANUARY 11, 2023

Supported by landmark clinical data from a Phase III trial, next-in-class anti-Aβ monoclonal antibody (MAb) lecanemab appears poised for full US FDA approval and ex-US launches. Lecanemab and Donanemab are poised to help treat early-stage Alzheimer’s disease. Donanemab, and others in the class (e.g.,

Drugs 52

Drugs Development Trials Antibody 52

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Initiate treatment with insulin as clinically indicated. after the Selected Important Safety Information.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Monoclonal Antibodies. The human monoclonal antibody targets specific immune plasma cells. The cells secrete auto-antibodies, but do not respond to standard immunosuppression.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

JULY 23, 2021

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

MARCH 11, 2021

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Trials 52

Trials Hormones Genome Genomics 52