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Phase 3 study of KEYTRUDA monotherapy meets primary endpoint

Merck, known as MSD outside the United States and Canada, announced today that the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma, met a primary endpoint of overall survival as monotherapy in patients whose tumors expressed PD-L1.

25 Jul 2018

FDA approves first drug for treatment of adult AML patients with specific genetic mutation

The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.

20 Jul 2018

AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia

AbbVie, a research-based global biopharmaceutical company, today announced it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for venetoclax in combination with a hypomethylating agent or in combination with low-dose cytarabine for the treatment of newly diagnosed patients with acute myeloid leukemia who are ineligible for intensive chemotherapy.

20 Jul 2018

Researchers find that yellow fever and Asian tiger mosquitoes can carry new virus

A virus responsible for an illness outbreak in Venezuela is spreading to other parts of the Americas, says a University of Florida scientist who is closely monitoring the Mayaro virus.

18 Jul 2018

High opioid doses, concurrent sedative use are key factors for overdose risk in Medicaid recipients

Among Medicaid recipients taking prescription opioids, high opioid doses and concurrent treatment with benzodiazepine sedatives are among the key, potentially modifiable risk factors for fatal overdose, reports a study in the August issue of Medical Care.

13 Jul 2018

Study identifies constellation of metabolites linked to ME/CFS

A study led by researchers at the Center for Infection and Immunity at Columbia University's Mailman School of Public Health has identified a constellation of metabolites related to myalgic encephalomyelitis/chronic fatigue syndrome.

10 Jul 2018

Zika virus-related pregnancy loss in humans may be more common than thought

Fetal death in utero occurred in more than one-fourth of monkeys infected in the laboratory with Zika virus in early pregnancy, according to new research published in Nature Medicine.

3 Jul 2018

Merck announces FDA acceptance of supplemental Biologics License Application for KEYTRUDA

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted for standard review a new supplemental Biologics License Application for KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act, or target action, date of February 16, 2019.

25 Jun 2018

New study examines how the brain plays role in rheumatoid arthritis inflammation

In patients with chronic inflammatory conditions, such as rheumatoid arthritis, there has been limited understanding of how this inflammation affects the brain.

18 Jun 2018

Study: Lenabasum has acceptable safety and tolerability in diffuse cutaneous systemic sclerosis

The results of an open label extension of a phase II study presented today at the Annual European Congress of Rheumatology, 2018, demonstrate that lenabasum continues to have acceptable safety and tolerability in diffuse cutaneous systemic sclerosis with no severe or serious adverse events.

18 Jun 2018

Scientists develop artificial intelligence platform to diagnose many diseases

A platform that can diagnose several diseases with a high degree of precision using metabolic markers found in patients' blood has been developed by scientists at the University of Campinas in Brazil

13 Jun 2018

Limiting global warming could reduce millions of dengue cases every year

Limiting global warming to 1.5°C could avoid around 3.3 million cases of dengue fever per year in Latin America and the Caribbean alone - according to new research from the University of East Anglia.

28 May 2018

FDA approves novel enzyme therapy for adults with rare and serious genetic disease

The U.S. Food and Drug Administration today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU).

25 May 2018

Scientists identify new drug target to combat chikungunya virus

Scientists have identified a molecule found on human cells and some animal cells that could be a useful target for drugs against chikungunya virus infection and related diseases, according to new research published in the journal Nature.

21 May 2018

Study finds molecular handle that chikungunya virus uses to enter into cells and cause arthritis

Chikungunya virus is a growing threat to the United States and other regions of the world as the mosquito that carries the virus expands its reach. Telltale symptoms of chikungunya infection are fever and joint pain that last about a week.

17 May 2018

First epoetin alfa biosimilar receives FDA approval to treat certain types of anemia

The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.

16 May 2018

FDA grants approval for two drugs administered together to treat aggressive form of thyroid cancer

The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).

8 May 2018

FDA approves new treatment for non-metastatic, castration-resistant prostate cancer

The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.

15 Feb 2018

Trial shows safety, feasibility of adding immunotherapy during chemoradiation for head and neck cancer

Analysis of a clinical trial, RTOG Foundation 3504, finds that nivolumab immunotherapy can be administered safely in conjunction with radiation therapy and chemotherapy for patients with newly diagnosed local-regionally advanced head and neck cancers.

13 Feb 2018

Many Indians put away treating orthopedic problems

While India has witnessed an increase in life expectancy thanks to advances in medical science and technology, what is also increasing is the number of people leading sedentary lifestyles and eating food that is unhealthy.

22 Jan 2018