New Approvals – Page 18

FDA approves algorithm that predicts sudden patient deaths to help prevent them

Wave Clinical Platform is the work of ExcelMedical and is a system that monitors patients' vital signs, sending alerts that warn of potentially fatal heart attacks or respiratory failure up to six hours before a patient suffers such an event.

Source: Digital Trends
512
January 16, 2018

FDA approves first treatment for breast cancer with a certain inherited genetic mutation

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.

Source: finance.yahoo
558
January 15, 2018

breast cancer Lynparza metastasized New Approvals

Eisai and Merck Receive Breakthrough Therapy Designation from FDA for LENVIMA® (lenvatinib mesylate) and KEYTRUDA® (pembrolizumab)

Eisai Co., Ltd. and Merck (MRK), known as MSD outside the United States and Canada, announced that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC).

Source: finance.yahoo
540
January 11, 2018

LENVIMA New Approvals RCC

FDA Accepts New Drug Applications for Merck’s Doravirine

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults.

Source: investors.merck
521
January 11, 2018

doravirine NDAs New Approvals NNRTI

Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced that its New Drug Application (NDA) for inotersen has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA). Inotersen is an investigational drug for the treatment of patients with hereditary TTR amyloidosis (hATTR). Priority Review is granted by the FDA to drugs with the potential to address a serious condition and, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of July 6, 2018. “TTR amyloidosis is a progressive, fatal disease with very limited treatment options. Receiving Priority Review in the U.S. and Accelerated Assessment in the EU for inotersen shows that the regulatory agencies recognize the high unmet need and the urgency to identify effective therapies to treat patients with this devastating disease,” said Sarah ...

Source: Prnewswire;
483
January 10, 2018

FDA hATTR New Approvals TTR amyloidosis

US awards Novartis’ Kisqali ‘Breakthrough’ status

Novartis’ CDK4/6 inhibitor Kisqali has picked up Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer.

Source: pharmatimes
564
January 4, 2018

inhibitor Kisqali New Approvals

After disappointing 2016, new drug approvals roared back to life in 2017

New drug approvals all but screeched to a halt in 2016, with a measly 22 new OKs after a pair of bountiful years. But the FDA wasted no time in 2017, signing off on 12 drugs in the first quarter alone—besting its record for the same period of any year in recent history.

Source: fiercebiotech
630
January 4, 2018

CAR-T therapy FDA New Approvals new drug

FDA Approves Angiotensin-II for Septic Shock

The FDA approved angiotensin-II (Giapreza) as a new intravenous vasopressor for septic shock and other forms of distributive shock. The first new FDA-approved vasopressor in decades, angiotensin-II could significantly change the management of severe septic shock.

Source: PulmCCM
529
January 3, 2018

FDA New Approvals sepsis septic shock

U.S. FDA Grants Priority Review to Janssen for Apalutamide as a Treatment for Non-Metastatic Castration-Resistant Prostate Cancer

Janssen Biotech, Inc. (Janssen) announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for apalutamide, an investigational, next-generation oral androgen receptor (AR) inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC.

Source: Janssen
494
December 25, 2017

CRPC inhibitor New Approvals

U.S. FDA approves new diabetes drug from Merck and Pfizer

A new drug developed by Merck & Co and Pfizer Inc won U.S. approval on Wednesday to treat type II diabetes, the Food and Drug Administration(FDA) said, adding another competitor to a growing class of treatments.

Source: Reuters
694
December 25, 2017

ertugliflozin Merk New Approvals Pfizer

FDA approves algorithm that predicts sudden patient deaths to help prevent them

FDA approves first treatment for breast cancer with a certain inherited genetic mutation

Eisai and Merck Receive Breakthrough Therapy Designation from FDA for LENVIMA® (lenvatinib mesylate) and KEYTRUDA® (pembrolizumab)

FDA Accepts New Drug Applications for Merck’s Doravirine

Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

US awards Novartis’ Kisqali ‘Breakthrough’ status

After disappointing 2016, new drug approvals roared back to life in 2017

FDA Approves Angiotensin-II for Septic Shock

U.S. FDA Grants Priority Review to Janssen for Apalutamide as a Treatment for Non-Metastatic Castration-Resistant Prostate Cancer

U.S. FDA approves new diabetes drug from Merck and Pfizer

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