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. This marks the first time an anti-PD-1 therapy has been approved in combination with anantibody-drug conjugate in the U.S.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

AUGUST 17, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). As we saw in the GARNET trial, of those patients who respond to treatment with dostarlimab, nearly all continued to respond for six months or longer.”. by blinded independent central review.

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

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. billion the drug generated in 2021. billion in 2022. billion in 2022.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial.

Trials 52

Trials Hormones Genome Genomics 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

JULY 22, 2021

The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; KENILWORTH & WOODCLIFF, N.J.–(BUSINESS

HR 52

HR Trials Dermatology Hormones 52

The Pharma Data

AUGUST 3, 2021

We expect that recovery in the dermatology segment will continue to progress over the coming quarters. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA has assigned a Prescription Drug User Fee Act action date of December 19, 2021.

Sales 52

Sales Production Antibody Development 52