Latest News

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new oral treatment for multiple sclerosis

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

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.

FDA Market Clearance for new Cranial Electrotherapy Stimulator

A new treatment for anxiety, depression and insomnia may be on the way now that Innovative Neurological Devices received FDA market clearance for its Cervella Cranial Electrotherapy Stimulator (CES).

Medical screw with superalloy receives FDA approval

The Europa Pedicle Screw System received FDA 510(k) approval at the end of March.

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

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

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

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

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

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

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

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

FDA releases statement on new policies to curb youth access to flavored tobacco products

The Food and Drug Administration is looking toward a future where combustible cigarettes are not addictive and do not harm as many people as are currently affected by nicotine and additive chemicals.

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

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

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

Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.

ALLERGAN, PLC: Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients

Label Now Includes New Data on Use of AVYCAZ for Treatment of cUTI and cIAI in Pediatric Patients 3 Months of Age and Older

FDA Health News