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.” Almirall S.A.’s ’s Chief Scientific Officer. About Lebrikizumab.

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

pharmaphorum

SEPTEMBER 2, 2022

German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US. The post Boehringer bags first approval for rare skin disease drug appeared first on.

Drugs 99

Drugs Antibody FDA Approval Trials 99

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

MARCH 18, 2022

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab 1. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.1

Antibody 52

Antibody HR Dermatology Trials 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 8, 2021

KEYTRUDA Is Now Approved for the Treatment of Patients With Recurrent or Metastatic or Locally Advanced cSCC That Is Not Curable by Surgery or Radiation. 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. 1) as determined by an FDA-approved test.

FDA Approval 52

FDA Approval Containment Trials Genome 52

The Pharma Data

OCTOBER 9, 2021

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). Currently there are no FDA-approved treatments for EoE. Patients are often treated with corticosteroids to manage inflammation.

Drugs 52

Drugs Sales Medicine Dermatology 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 Doctors Doctor Development 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. in these patients. Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

MARCH 23, 2021

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression. Under this project, the FDA, Australian Therapeutic Goods Administration, Health Canada and Swissmedic collaboratively reviewed the KEYNOTE-590 application.

HR 52

HR FDA Approval Containment Genome 52

The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA), Bristol Myers Squibb has made the difficult decision to voluntarily withdraw the indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib from the U.S. In consultation with the U.S.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) between April 27-29, 2021 to discuss accelerated approvals in oncology impacted as part of the Agency’s industry-wide review. endocrinopathies and dermatologic reactions) are discussed below.

Trials 52

Trials Hormones Genome Genomics 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

In October 2019, GSK filed a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for Trelegy Ellipta for the treatment of asthma in adults. REGN3500 is being studied in Phase II trials for asthma, chronic obstructive pulmonary disease and atopic dermatitis.

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