New Approvals – Page 21 – media

FDA Clears First Device to Help Curb Opioid Cravings

The US Food and Drug Administration (FDA) has approved a device designed to reduce the symptoms of opioid withdrawal.
- Source: medscape
- 574
- November 16, 2017
cranial nerves FDA New Approvals opioid stimulator
Boehringer bags first biosimilar approval in the EU

Boehringer Ingelheim has won its first biosimilar approval in Europe with authorisation of Cyltezo for a range of chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
- Source: Pharmatimes
- 594
- November 16, 2017
arthritis biosimilar chronic Cyltezo New Approvals
AstraZeneca-FASENRA Gets US FDA Approval For Severe Eosinophilic Asthma

AstraZeneca and its global biologics research and development arm, MedImmune, said Tuesay that the US Food and Drug Administration has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
- Source: businessinsider
- 568
- November 15, 2017
asthma eosinophilic Market Views New Approvals
Perflow Medical Announces Issuance of Patent for The Stream™ Dynamic Neuro-Thrombectomy Net to Improve Thrombus Removal Post-Stroke

Perflow Medical, an Israeli-based medtech company focused on next-generation neurointerventional devices,announced the issuance of U.S. Patent No. 9510855, by the U.S. Patent and Trademark Office (USPTO), for the Stream™ Dynamic Neuro-Thrombectomy Net. This is the first device to provide full dynamic wall apposition during the treatment of acute ischemic stroke.
- Source: Prnewswire
- 540
- November 15, 2017
ischemic stroke neurointerventional New Approvals
US regulators approve first digital pill to track patients

US regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns. The digital pill approved Monday combines two existing products: the former blockbuster psychiatric medication Abilify—long used to treat schizophrenia and bipolar disorder—with a sensor tracking system first approved in 2012.
- Source: medicalxpress
- 506
- November 15, 2017
bipolar disorder blockbuster New Approvals psychiatric schizophrenia
Merck Receives FDA Approval of PREVYMIS™ (letermovir)

Merck & Co., Inc. (MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
- Source: finance.yahoo
- 1,107
- November 10, 2017
CMV FDA HSCT New Approvals
FDA Approves Genentech’s Alecensa Lung Cancer Treatment

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
- Source: Pharmpro
- 602
- November 9, 2017
ALK FDA New Approvals NSCLC sNDA
EU OKs low-dose Xarelto to prevent recurrent VTE

A lower dose formulation of Bayer and Janssen’s bloodthinner Xarelto has been approved by European regulators for preventing recurrent venous thromboembolism, expanding treatment options for patients.
- Source: Pharmatimes
- 622
- November 8, 2017
cardiovascular New Approvals venous thromboembolism VTE
GSK’s investigational BCMA antibody-drug conjugate receives Breakthrough Therapy Designation from US FDA for relapsed and refractory multiple myeloma

In October, the European Medicines Agency (EMA) granted PRIME designation to GSK2857916 for the treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate.
- Source: gsk
- 556
- November 3, 2017
inhibitor multiple myeloma New Approvals refractory relapsed
AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

AbbVie, a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. , announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated for the management of endometriosis with associated pain.
- Source: news.abbvie
- 736
- November 2, 2017
antagonist biopharmaceutical GnRH New Approvals

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