Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

FDA Approval 40

FDA Approval Clinical Trials Clinical Trials Trials 40

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.

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

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 22, 2021

3 “Nivolumab provides a new FDA-approved treatment shown to reduce the risk of disease recurrence or death based on the safety and efficacy findings from CheckMate -274, and has the potential to become a new standard of care option in this setting.” Galsky,* M.D., 1 Please see Important Safety Information below.

Drugs 52

Drugs HR FDA Approval Trials 52

The Pharma Data

DECEMBER 30, 2020

When the deal was struck, J&J said nipocalimab provides the company with an opportunity to reach more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology.

Antibody 52

Antibody Allergies Branding Dermatology 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

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

Delveinsight

AUGUST 13, 2020

It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler. 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

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

The Pharma Data

APRIL 4, 2023

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. INDIANAPOLIS , Oct. Skin-related diseases are more than skin deep.

Dermatology 52

Dermatology Development Medicine Clinical Trials 52

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

DECEMBER 20, 2023

Novo Nordisk’s GLP-1 weight loss-specific drug Wegovy (semaglutide) has been facing similar shortages, as it contains the same active ingredient as Ozempic. The companies include a diverse range engaged in innovative approaches in areas like oncology, genetic medicines, inflammatory diseases, dermatology and cardiorenal therapy.

Life Science 59

Life Science Clinical Trials Clinical Trials FDA Approval 59

The Pharma Data

APRIL 26, 2021

COVID-19 negatively impacted demand, particularly: dermatology, ophthalmology, the breast cancer portfolio, Sandoz Retail and Anti-Infectives. New approvals. Adakveo sales reached USD 37 million. Sandoz sales declined -13% (cc, -9% USD), with Retail -18% (cc) and Biopharmaceuticals growing +7% (cc). Exjade/Jadenu. Entresto. .

Sales 40

Sales Medicine Production Manufacturing 40

Pfizer

OCTOBER 28, 2022

In addition to receiving regulatory approval in the U.S., CIBINQO FDA-APPROVED INDICATION. DISCLOSURE NOTICE: The information contained in this release is as of October 28, 2022. Refer to the full prescribing information for recommended dosage and dosage adjustments for XELJANZ.

Clinical Trials 40

Clinical Trials Clinical Trials Vaccine Vaccination 40