The Pharma Data

DECEMBER 30, 2020

billion acquisition of immuno-oncology company Forty Seven and its lead asset, magrolimab, a monoclonal antibody in the clinic for several cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). It began in May with the $4.9 Magrolimab targets CD47. Most Read Today.

Antibody 52

Antibody Allergies Branding Dermatology 52

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

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

pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. Otezla – which Amgen acquired for $13.4

Drugs 52

Drugs FDA Approval Licensing Licensing 52

XTalks

AUGUST 7, 2024

This includes Bristol Myers Squibb’s Sotyktu (deucravacitinib), which received US Food and Drug Administration (FDA) approval in 2022. Up until this year, AbbVie’s anti-inflammatory monoclonal antibody Humira (adalimumab) reigned as the world’s best-selling drug for the past several years.

FDA Approval 52

FDA Approval Genetics Antibody Drugs 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. Immune-Mediated Dermatologic Adverse Reactions KEYTRUDA can cause immune-mediated rash or dermatitis.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) approval of Dupixent in September 2022 and the European Medicines Agency approval of Dupixent in December 2022. Dupixent is the only approved biologic indicated for prurigo nodularis in the U.S. Results from the trials were the basis for the U.S. Gil Yosipovitch, M.D.

Medicine 40

Medicine Trials Dermatology FDA Approval 40

The Pharma Data

OCTOBER 9, 2021

Currently there are no FDA-approved treatments for EoE. The Company’s growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases.

Drugs 52

Drugs Sales Medicine Dermatology 52

The Pharma Data

JUNE 7, 2022

. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” EASI=Eczema Area and Severity Index, EASI-75=75 percent reduction in EASI from baseline to Week 16.

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

The Pharma Data

MARCH 23, 2021

Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. 1] as determined by an FDA-approved test.

HR 52

HR FDA Approval Containment Genome 52

The Pharma Data

AUGUST 3, 2021

We expect that recovery in the dermatology segment will continue to progress over the coming quarters. Looking forward, we are preparing for the anticipated approval of the mild-to-moderate psoriasis indication in the U.S., For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies.

Sales 52

Sales Production Antibody Development 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. endocrinopathies and dermatologic reactions) are discussed below.

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. endocrinopathies and dermatologic reactions) are discussed below.

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

MARCH 16, 2021

These data will be presented virtually in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference, March 16–20, 2021. 1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. TREMFYA q4w is not currently FDA-approved. Clinically meaningful defined as ?3

Medicine 52

Medicine Doctor Doctors Development 52

The Pharma Data

AUGUST 11, 2020

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. Immune-Mediated Skin and Dermatologic Adverse Reactions.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

Delveinsight

AUGUST 13, 2020

SAR440340 History: Regeneron and Sanofi are currently studying REGN3500 in respiratory and dermatological diseases where inflammation is thought to play an underlying role. Along the way, Regeneron has opted to co-promote Dupixent, now approved to treat severe eczema, asthma and nasal polyps; Praluent; and Kevzara in the U.S.

Antibody 40

Antibody Medicine Trials Development 40

The Pharma Data

AUGUST 11, 2020

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. Immune-Mediated Skin and Dermatologic Adverse Reactions.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

XTalks

DECEMBER 18, 2024

Cosibelimab-ipdl is a monoclonal antibody that inhibits PD-L1, a protein that tumors use to evade immune detection. Olivier also explained that Unloxcyt has also shown the ability to induce antibody-dependent cell-mediated cytotoxicity (ADCC), differentiating it from existing marketed therapies for patients with cSCC.

FDA Approval 95

FDA Approval Antibody Immune Response Marketing 95

XTalks

JANUARY 2, 2025

Since its FDA approval in 2017, Regeneron and Sanofi’s Dupixent has been hailed as an innovative treatment for patients with atopic dermatitis, with industry experts describing it as “life-changing.” ” Over the years, Regeneron has expanded Dupixents approved uses, most notably into asthma.

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Sales FDA Approval Drugs Marketing 85