Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

HR 264

HR Hormones FDA Approval Antibody 264

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

Pharmaceutical Technology

SEPTEMBER 13, 2022

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. Trop-2 is highly expressed across multiple cancer types, with expression detected in more than 90% of breast cancers.

HR 162

HR Marketing Hormones FDA Approval 162

The Pharma Data

APRIL 7, 2021

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months vs. 6.9

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

JANUARY 4, 2021

months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Co-primary endpoints are overall response rate and progression-free survival.

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. Beyond the regulatory approvals of Trodelvy in the U.S., FOSTER CITY, Calif.–(BUSINESS

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. No dosage adjustment is needed in patients with mild renal impairment.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

JUNE 18, 2021

1 With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent IMBRUVICA was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111–0.230]). The BTK protein sends important signals that tell B cells to mature and produce antibodies. Isolated growth hormone deficiency. ?

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. Isolated growth hormone deficiency. ?

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

MAY 4, 2021

and developed Europe following the approvals in 2019 for combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma; as well as. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Vaccination 40

Vaccination Vaccine Production Sales 40