The Pharma Data

AUGUST 22, 2021

1 Opdivo reduced the risk of disease recurrence or death by 30% compared to placebo (Hazard Ratio [HR] 0.70, 95% CI: 0.57 n=142) for placebo; Opdivo reduced the risk of disease recurrence or death by 45% (HR 0.55, 95% CI: 0.39 months [95% Confidence Interval (CI): 16.5 months [95% CI: 8.3 to 13.9]). to 0.86; P =0.0008).

Drugs 52

Drugs HR FDA Approval Trials 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

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];

HR 52

HR Trials Dermatology Hormones 52

The Pharma Data

MARCH 23, 2021

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

HR 52

HR FDA Approval Containment Genome 52

The Pharma Data

MARCH 18, 2022

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 1 The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag (n=355) to nivolumab alone (n=359).1,2 to 5.6); (Hazard Ratio [HR] 0.75; 95% CI: 0.62

Antibody 52

Antibody HR Dermatology Trials 52