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
Latest News
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
12 drugs recalled in first 60 days of 2019, FDA reports
Twelve prescription drugs were recalled in January and February to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
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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
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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.
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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.
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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.
FDA approves quicker Strep A test
A global company has had its third test cleared by the U.S. Food and Drug Administration which this month approved GenePOC’s Strep A assay, which provides in vitro diagnosis of Strep A infections within an hour.
FDA approves Optimizer Smart System for heart patients
The U.S. Food and Drug Administration estimates that nearly 6 million Americans have heart failure — the organ can’t keep up with their bodies’ needs.
FDA seeks to modernize protocols in response to 'precision medicine'
Getting effective treatments for diseases and conditions to people as quickly as possible while guaranteeing their safety and efficacy, as well as protecting the safety of trial subjects, has always been a delicate balancing act for the U.S. Food and Drug Administration (FDA), the federal agency responsible for the safety of pharmaceuticals and medical devices, among other things.
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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
U.S. FOOD AND DRUG ADMINISTRATION: FDA Accepts the Citizen Petition by Prof. Niazi, to Withdraw the Naming Guidance for Biosimilars
The FDA has accepted the petition for review and designated it as FDA 2019-P-1236.
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.
FDA Update: January-February medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the Food and Drug Administration.
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
PHARMACEUTICS INTERNATIONAL, INC.: Pii to Manufacture FDA-approved Busulfan Injection Drug Product
Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the launch of Busulfan Injection, 6mg/mL in 10mL vials, in partnership with Athenex Pharmaceuticals, Sungen Pharma and Chemwerth.