The Pharma Data

APRIL 11, 2021

FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

JULY 8, 2021

This approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated an objective response rate (ORR) of 50% (95% CI, 36-64) (n=54), including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease.

FDA Approval 52

FDA Approval FDA Treatment Therapies 52

The Pharma Data

JULY 6, 2021

accelerated approval indication for KEYTRUDA for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS ?1)] 1) as determined by an FDA-approved test. 1)] as determined by a U.S.

FDA Approval 52

FDA Approval FDA Treatment Therapies 52

Alta Sciences

APRIL 4, 2025

Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me pmjackson Fri, 04/04/2025 - 18:01 By Josiah Liang, Research Laboratory Technician, Clinical Diagnostic and Central Laboratory Services. How Clinical Research Saved My Life I was born in 2000.

Clinical Research 52

Clinical Research Science Research Research Laboratories 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.

Treatment 52

Treatment FDA Approval FDA Therapies 52

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. PAH is a chronic, progressive disease caused by the hardening and narrowing of the pulmonary arteries that can cause right heart failure and eventual death. The drug also received Rare Pediatric Disease Designation for these indications. Source link.

FDA 52

FDA Licensing Licensing Treatment 52

The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

FDA 40

FDA FDA Approval Trials Treatment 40

The Pharma Data

JULY 22, 2021

Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma That is Not Microsatellite Instability-High or Mismatch Repair Deficient, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation.

Therapies 52

Therapies Treatment Disease Trials 52

The Pharma Data

JULY 15, 2021

EFS was defined as the time from randomization to the first occurrence of either disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause. KEYTRUDA is currently approved under accelerated approval in the U.S. 10) as determined by an FDA-approved test.

Therapies 52

Therapies Treatment Trials FDA 52

Codon

JUNE 18, 2024

Dr. Karl Dussik, an Austrian physician, was among the first to suggest that ultrasound could be used to diagnose diseases within the body in 1941. By 2016, Shapiro had set up a research laboratory at the California Institute of Technology in Pasadena and began to devote his attention entirely to gas vesicles.

Engineering 71

Engineering Laboratories International Clinical Trials 71

Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Read “Nanoscope's phase 2 win for gene therapy shows potential of light-sensitive approach to eye disease.” Nature Neuroscience. Read You love to see it!

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

APRIL 4, 2023

Patients were treated until disease progression or unacceptable toxicity. Thirty-seven percent of patients had upper tract disease. Patients in the dose escalation cohort (n=5), Cohort A (n=40), and Cohort K (n=76) received enfortumab vedotin 1.25 A total of 121 patients received KEYTRUDA in combination with enfortumab vedotin.

Treatment 40

Treatment FDA Approval FDA Therapies 40

The Pharma Data

JULY 18, 2021

VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and make recommendations on the use of VAXNEUVANCE in adults.

Disease 52

Disease Immune Response Vaccine FDA Approval 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

The Pharma Data

JULY 21, 2021

Bayer also issued a news release earlier today announcing the EC approval. Food and Drug Administration (FDA) approved VERQUVO in the U.S. The approval of VERQUVO in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.”.

Treatment 52

Treatment Production Disease Hospitals 52

The Pharma Data

MARCH 15, 2022

“There remains a significant unmet need for patients diagnosed with advanced prostate cancer, who have a poor prognosis after not responding to initial therapy,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Merck’s Focus on Cancer.

DNA 52

DNA Clinical Trials Trials Therapies 52

The Pharma Data

JANUARY 26, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. www.lilly.com?and?www.lilly.com/news.?P-LLY.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

Codon

JANUARY 26, 2025

Astrologers of the time believed that the disease’s periodic return was influenced by the location of the stars. By contrast, smallpox and measles vaccines are more than 95 percent effective at preventing disease, a level sufficient to have eradicated smallpox entirely. Formaldehyde had precedent in medicine.

Vaccine 116

Vaccine Virus Immune Response Clinical Trials 116

Broad Institute

NOVEMBER 6, 2024

Kerry Reynolds: The first immune checkpoint inhibitor was FDA-approved in 2011 to treat melanoma, with nearly a dozen more ICIs approved for various cancers since then. How big of a problem are these complications from cancer immunotherapy? These are home-run, breakthrough therapies, and quite an amazing success story.

Research 131

Research Immune Response Hospitals Therapies 131

Codon

APRIL 4, 2025

Smallpox was so feared that “no man dared to count his children as his own until they had the disease,” the French explorer Charles Marie de La Condamine once asserted. Crude as it was by today’s standards, Jenner’s vaccine played an enormous role in curbing the disease’s spread.

Immune Response 97

Immune Response Vaccine Virus Disease 97