Press release submission Stories

By Press release submission | Apr 2, 2019

The U.S. Food and Drug Administration today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves treatment for patients with a type of inflammatory arthritis

By Press release submission | Apr 2, 2019

The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation.

LUYE PHARMA: Luye Pharma's Rykindo® Expected to Be the First Chinese Innovative Drug to Receive U.S. FDA Approval

Luye Pharma Group has announced submission of a new drug application (NDA) to the U.S. Food and Drug Administration ("FDA") for Rykindo®, completed on March 28. Rykindo® (LY03004) Risperidone Extended-release Microsphere for Injection is expected to become the first Chinese innovative drug to receive U.S. FDA approval for marketing in the United States.

UCB, INC.: CIMZIA® (certolizumab pegol) is Now the First and Only U.S. FDA-Approved Treatment for Non-Radiographic Axial Spondyloarthritis

Patients living with non-radiographic axial spondyloarthritis, an often undiagnosed, chronic, painful and debilitating disease, now have an approved, clinically validated treatment

OLYMPUS MEDICAL SYSTEMS GROUP: First Patient Treated for Severe Emphysema with the FDA-Approved Spiration® Valve System

Novel, effective endobronchial valve treatment now used by physician at hospital in Philadelphia

EMD SERONO, INC.: FDA Approves MAVENCLAD® (Cladribine) Tablets as First and Only Short-Course Oral Treatment for Relapsing-Remitting and Active Secondary Progressive Multiple Sclerosis

MAVENCLAD is the first oral MS treatment to provide two years of proven efficacy with a maximum of 20 days of treatment

JANSSEN PHARMACEUTICALS, INC.: Janssen Submits Supplemental New Drug Application to U.S. FDA for INVOKANA® (canagliflozin) for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes

Regulation

By Press release submission | Mar 28, 2019

If approved, INVOKANA® will be the first and only therapy in nearly 20 years indicated to reduce the risk of end-stage kidney disease when added to current standard of care

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism

By Press release submission | Mar 28, 2019

The U.S. Food and Drug Administration approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new oral drug to treat multiple sclerosis

By Press release submission | Mar 28, 2019

The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

U.S. FOOD AND DRUG ADMINISTRATION: FDA advances landmark policy changes to modernize mammography services and improve their quality

By Press release submission | Mar 27, 2019

Proposed rule would require breast density reporting, enhance the FDA’s ability to enforce mammography facilities’ compliance with standards

NEURONIX LTD: neuroAD™ Therapy System for Treatment of Mild-to-Moderate Alzheimer's Disease Considered by FDA Neurological Devices Advisory Committee

By Press release submission | Mar 26, 2019

Neuronix Ltd. announced that the U.S. Food and Drug Administration (FDA) Neurological Devices Advisory Committee met on March 21 to consider data and receive public comment about the neuroAD™ Therapy System, a non-invasive medical device for the treatment of mild-to-moderate Alzheimer's disease.

ZIMMER BIOMET: Receives FDA Clearance of ROSA® ONE Spine System for Robotically-Assisted Surgeries

By Press release submission | Mar 25, 2019

Zimmer Biomet becomes first company in the world with 510(k) clearance for Brain, Spine and Knee offerings on one robotic platform

U.S. FOOD AND DRUG ADMINISTRATION: FDA Accepts the Citizen Petition by Prof. Niazi, to Withdraw the Naming Guidance for Biosimilars

Reform

By Press release submission | Mar 23, 2019

The FDA has accepted the petition for review and designated it as FDA 2019-P-1236.

NEUROTROPE INC.: Neurotrope Comments On Biogen's Discontinued Phase 3 Trial In Alzheimer's Disease

By Press release submission | Mar 22, 2019

Neurotrope Inc. (Nasdaq: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today issued a statement on Biogen Inc.'s decision to discontinue its global Phase 3 trials of aducanunab in Alzheimer's disease.

VIOME: Viome and Helomics Partner to Identify Personalized Treatment for Ovarian Cancer Patients

By Press release submission | Mar 21, 2019

Viome, a company transforming health through personalized nutrition based on individual biology, today announces it will collaborate with precision health leader, Helomics, to study the link between the gut microbiome and ovarian cancer.

BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.: Announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD