Thrombocytopenia News and Research

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Thrombocytopenia is a condition in which there is a lower-than-normal number of platelets in the blood. It may result in easy bruising and excessive bleeding from wounds or bleeding in mucous membranes and other tissues.

Novartis announces FDA approval of its first and only CML therapy with TFR data in product label

Novartis announced today that the US Food and Drug Administration (FDA) approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna® (nilotinib) US product label.

26 Dec 2017

FDA grants approval to first biosimilar for treatment of patients with breast, stomach cancers

The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).

4 Dec 2017

Experts endorse recommendations for restrictive blood transfusions

By analyzing data from randomized clinical trials comparing blood transfusion approaches, Johns Hopkins experts, along with colleagues at Cleveland Clinic and NYU Langone Medical Center, endorse recommendations for blood transfusions that reduce blood use to improve patient safety and outcomes.

20 Nov 2017

FDA approves first adjuvant treatment to reduce risk of kidney cancer recurrence

The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy).

17 Nov 2017

FDA grants accelerated approval to new treatment for mantle cell lymphoma

The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

1 Nov 2017

Biogen and Ionis awarded 2017 Prix Galien USA Award for SPINRAZA

Biogen and Ionis have been awarded the prestigious 2017 Prix Galien USA Award for Best Biotechnology Product for SPINRAZA (nusinersen). The Prix Galien USA Award recognizes extraordinary achievement in scientific innovation that improves the state of human health. The award was presented at a ceremony in New York City on October 26, 2017.

30 Oct 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

FDA grants accelerated approval to new drug for treating relapsed follicular lymphoma

The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

14 Sep 2017

FDA approves drug to treat patients with newly diagnosed CD33-positive AML

The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML).

1 Sep 2017

Pfizer receives FDA approval for new therapy to treat adults and children with AML

Pfizer Inc. today announced that the U.S. Food and Drug Administration approved MYLOTARG (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.

1 Sep 2017

$FDA approval provides new, targeted treatment option for adults with relapsed or refractory B-cell ALL$

FDA approval provides new, targeted treatment option for adults with relapsed or refractory B-cell ALL

The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

17 Aug 2017

Mice study reveals how natural killer cells in the placenta can cause miscarriages

Researchers at St. Michael's Hospital have identified how natural killer cells in the mouse placenta can cause a fetus to fail to grow in the womb or cause miscarriages.

9 Aug 2017

UNC-Chapel Hill researchers find undesirable issues with widely-used drug screening tool

A widely used screening tool deployed in the early phases of drug discovery to weed out undesirable compounds is wrong so often it can't be trusted on its own, according to scientists at the University of North Carolina at Chapel Hill.

11 Jul 2017

New discovery may be key to stopping shortages of vital blood-clotting cells

The emergency call issued by the American Red Cross earlier this year was of a sort all too common: Donations of platelets were needed, and desperately.

19 May 2017

Study: Use of white blood cell boosting drugs found to be safe during chemo-radiotherapy of lung cancer

A late breaking subanalysis of the phase III CONVERT trial presented at the European Lung Cancer Conference shows that white blood cell boosting drugs are safe during concurrent chemo-radiotherapy of small cell lung cancer (SCLC).

5 May 2017

Positive CHMP opinion recognizes efficacy of Biogen’s SPINRAZA for treatment of spinal muscular atrophy

Biogen today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the granting of a marketing authorization for SPINRAZA to treat patients with spinal muscular atrophy (SMA).

21 Apr 2017

FDA approves new maintenance therapy for recurrent cancers

The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.

27 Mar 2017

Ionis announces FDA approval of first SMA drug in the U.S for pediatric and adult patients

Ionis Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has approved SPINRAZATM (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

26 Dec 2016

FDA awards accelerated approval to new ovarian cancer drug

The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer.

19 Dec 2016

Long-term clinical data, experience supports effectiveness of PRRT for treating neuroendocrine tumors

More than ten years of published clinical data and personal experience using PRRT-based targeted therapy of neuroendocrine tumors supports the effectiveness of this novel treatment approach and the ability to minimize and manage potential toxic side effects.

17 Oct 2016