Delveinsight

DECEMBER 7, 2020

In April 2018, the FDA approved IDx ‘s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, a disorder that can lead to blindness. The device is worn on the patients’ body, which contains a biharmonic cartridge in it that carries insulin and glucagon.

Protein 56

Protein Insulin Hormones FDA Approval 56

Pfizer

JANUARY 27, 2023

Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

FEBRUARY 8, 2021

“The TITAN final analysis data confirm the long-term clinical benefit and consistent safety profile of ERLEADA ® plus ADT without a compromise in health-related quality of life,” said Mary Guckert, RN, MSN, Vice President, Development Leader, Prostate Cancer, Janssen Research & Development, LLC. About ERLEADA ® (apalutamide).

HR 52

HR Hormones Development Production 52

XTalks

FEBRUARY 7, 2023

The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.

HR 52

HR Hormones FDA Approval Antibody 52

The Pharma Data

AUGUST 17, 2021

Lyumjev U-200 contains 2 times as much insulin in 1 milliliter as Lyumjev U-100. Humalog U-100 contains 100 units of insulin per milliliter. All Lyumjev and Humalog products contain insulin lispro. drink alcohol or use other medicines that contain alcohol when taking your Lyumjev or Humalog. Learn more.

Insulin 52

Insulin FDA Approval Doctors Doctor 52

XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. About triple-negative breast cancer Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.1

Medicine 40

Medicine In-Vitro Antibody Development 40

XTalks

AUGUST 2, 2023

We delve into the driving forces behind their successes and shed light on the groundbreaking research that has earned them a place among the elite in the pharmaceutical arena. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion in 2022.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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

APRIL 7, 2021

Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need setting. The FDA granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a Phase 1/2 study.

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

JULY 23, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

JANUARY 4, 2021

We have been researching TIGIT as a novel cancer immunotherapy target for almost 10 years and we are pleased that the FDA has acknowledged the potential of tiragolumab to substantially improve outcomes for people with certain types of lung cancer,” said Levi Garraway, M.D., chief medical officer and head of Global Product Development.

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

FEBRUARY 8, 2021

Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “In In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”.

HR 52

HR In-Vitro Development Clinical Trials 52

The Pharma Data

MARCH 11, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated.

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. John’s?wort

Medicine 40

Medicine Production FDA Approval Trials 40

The Pharma Data

AUGUST 11, 2020

Bristol Myers Squibb: Advancing Cancer Research. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

JUNE 18, 2021

“With CLL being one of the most common types of blood cancer, the expansion of research into additional treatment options for patients is an important clinical undertaking,” said Arnon Kater , M.D., IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. and by AbbVie outside of the U.S.

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

AUGUST 11, 2020

Bristol Myers Squibb: Advancing Cancer Research. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

MAY 4, 2021

The findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. 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

Pharmaceutical Technology

MAY 11, 2023

The FDA has no obligations to follow the recommendation of AdComs, though the vote will likely be weighed in the agency’s final decision. The FDA approved Opill for prescription use in 1973. The therapy only contains the hormone progestin and is taken once daily.

FDA Approval 130

FDA Approval Hormones Drugs Containment 130