Search Results for “FDA” – Page 70 – media

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
- 517
- January 3, 2018
FDA New Approvals sepsis septic shock
FDA releases new guidelines for 3D printing devices

The U.S. Food and Drug Administration (FDA) has issued new guidelines related to the 3D printing of medical devices. FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice.
- Source: biospectrumasia
- 564
- December 27, 2017
3D printing FDA medical device polices
FDA clears Shire’s dosing software for haemophilia A SHARE

Irish biotechnology firm Shire has received 510(k) marketing clearance for its myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)] software from the US Food and Drug Administration (FDA).
- Source: medicaldevice-network
- 599
- December 26, 2017
ADVATE FDA haemophilia A Shire
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
- 484
- 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
- 682
- December 25, 2017
ertugliflozin Merk New Approvals Pfizer
Pfizer Announces FDA Approval of XELJANZ (tofacitinib) and XELJANZ XR for the Treatment of Active Psoriatic Arthritis

XELJANZ/XELJANZ XR, THE FIRST ORAL JAK INHIBITOR IN THE U.S. FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS, IS NOW APPROVED FOR ADULTS WITH ACTIVE PSORIATIC ARTHRITIS
- Source: Pfizer
- 517
- December 21, 2017
DMARDs New Approvals rheumatoid arthritis XELJANZ
FDA rolls out an early and historic OK for Spark’s pioneering gene therapy

Spark Therapeutics $ONCE has scored an historic FDA approval of Luxturna, the world’s first such AAV-delivered gene therapy designed to cure a rare eye disease triggered by a genetic mutation. The drug is OK’d for RPE65 mutation linked retinal dystrophy. The treatment uses a viral vector to insert the correct copy of a gene retinal cells need to create a protein that turns light into electric signals which can restore vision lost to the disease. As with the earlier pioneering approval of the world’s first CAR-T, FDA commissioner Scott Gottlieb did the honors in recognizing the importance of this approval. And he says the agency will make sure that the regulatory path is straight and clear for the rest of the field looking to following Spark’s footsteps. “We’re at a turning point when it comes to this novel form of therapy and at the FDA, we’re focused on establishing ...
- Source: drugdu
- 751
- December 20, 2017
FDA genetic mutation. Luxturna New Approvals rare eye disease
US FDA Accepts Regulatory Submission for TAGRISSO (Osimertinib) in 1st-Line EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of TAGRISSO® (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted TAGRISSO Priority Review status, and previously granted Breakthrough Therapy Designation for TAGRISSO in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.
- Source: finance.yahoo
- 606
- December 19, 2017
AstraZeneca CNS FDA New Approvals NSCLC TAGRISSO®
FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. Additionally, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.
- Source: finance.yahoo
- 566
- December 19, 2017
cluster headache FDA fremanezumab migraine New Approvals Teva
Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream, 1%, a Novel Topical Antibiotic for Impetigo

Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Xepi (ozenoxacin) Cream, 1%, a new chemical entity for the treatment of impetigo in patients two months of age and older when applied topically twice daily for 5 days. In the U.S., impetigo is estimated to account for approximately 10% of skin problems observed in pediatric clinics and is considered the most common bacterial skin infection.
- Source: drugs
- 652
- December 18, 2017
FDA impetigo New Approvals skin problems Xepi (ozenoxacin) Cream

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