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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

Ferring announces FDA approval of ZOMACTON for injection in four new pediatric indications

Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration has approved ZOMACTON for injection in four additional pediatric indications

20 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

Celgene to share new and updated data around novel hematological therapies

Celgene Corporation today announced that data from a broad range of early and late stage studies evaluating Celgene investigational agents and investigational uses of marketed products will be presented at the 23rd European Hematology Association annual meeting in Stockholm, Sweden, from June 14-17, 2018.

22 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

ACADIA Pharmaceuticals announces results from Phase II study of antipsychotic in Alzheimer's disease psychosis

ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced the presentation of data from the Phase II -019 Study of pimavanserin in Alzheimer's disease psychosis at the 10th Clinical Trials on Alzheimer's Disease meeting in Boston.

3 Nov 2017

First-ever treatment for Merkel cell carcinoma receives approval in Japan

Merck KGaA, Darmstadt, Germany, and Pfizer Inc. today announced that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved BAVENCIO (avelumab, genetically recombinant Injection 200mg/mL for intravenous use) as the first and only treatment indicated for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan.

27 Sep 2017

Experimental drug increases progression-free survival in pancreatic cancer patients, clinical trial shows

By adding an experimental drug to a standard chemotherapy regimen, a subset of patients with metastatic pancreatic cancer had a significantly longer period before the cancer progressed as compared with those who received the standard treatment, according to a Phase 2 clinical trial led by an investigator at Fred Hutchinson Cancer Research Center.

1 Jun 2017

FDA grants accelerated approval to new drug for treatment of rare form of skin cancer

The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy.

23 Mar 2017

European Commission approves extended indication for Amgen's Kyprolis (carfilzomib) for the treatment of relapsed multiple myeloma patients

Amgen has announced that the European Commission (EC) has approved a variation to the marketing authorization for Kyprolis® (carfilzomib) to include use in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy. The extended indication marks the second approval for Kyprolis by the EC in less than a year.

6 Jul 2016

Nuplazid (pimavanserin) tablets approved to treat hallucinations and delusions

The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson's disease.

30 Apr 2016

Novartis announces FDA approval of Afinitor for progressive, nonfunctional neuroendocrine tumors of GI

Novartis today announced that the United States Food and Drug Administration approved Afinitor (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.

26 Feb 2016

Results from STRIVE trial of enzalutamide versus bicalutamide in CRPC published in Journal of Clinical Oncology

Astellas US LLC, a United States (U.S.) subsidiary of Tokyo-based Astellas Pharma Inc., and Medivation, Inc. today announced that results from the STRIVE trial of enzalutamide compared to bicalutamide in men with castration-resistant prostate cancer (CRPC) were published in the Journal of Clinical Oncology.

27 Jan 2016

Lilly receives FDA approval for Humulin R U-500 KwikPen

The U.S. Food and Drug Administration has approved Eli Lilly and Company's Humulin R U-500 KwikPen(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin.

21 Jan 2016

Bayer to present new research findings on Xofigo (radium Ra 223 dichloride) injection at ASCO GU 2016

Bayer announced today that new research findings on Xofigo (radium Ra 223 dichloride) injection will be presented at the 2016 Genitourinary Cancers Symposium of the American Society of Clinical Oncology (ASCO GU) taking place January 7 – 9 in San Francisco.

4 Jan 2016

Ninlaro (ixazomib) approved to treat people with multiple myeloma

Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy.

21 Nov 2015

FDA approves Yondelis (trabectedin) for treatment of specific soft tissue sarcomas

The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic).

24 Oct 2015

First-in-human compassionate use cases with Edwards' FORMA transcatheter tricuspid repair system presented at TCT

Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that details on the 13 first-in-human compassionate use cases with its FORMA transcatheter tricuspid repair system were presented at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

15 Oct 2015

Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

"We are pleased to receive positive CHMP opinions for Kyprolis and BLINCYTO as this is an important step in providing new treatment options for patients in Europe with rare forms of cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

25 Sep 2015