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SPEEDX: Receives FDA Breakthrough Designation for ResistancePlus® GC
New diagnostic test enables antibiotic resistance testing and stewardship in gonorrhea treatment
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ORION BIOTECHNOLOGY: Announces Receipt of Pre-IND Guidance From the United States FDA on the Further Development of OB-002O as a Potential Treatment for Solid Tumors
Orion Biotechnology Canada Ltd., announced that it has received feedback from the Food and Drug Administration (FDA) on a Pre-Investigational New Drug (PIND) application which was submitted in March 2019.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma
The U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as “BR”), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.
VIVACELLE BIO, INC.: Announces Submission of an IND Application with U.S. FDA for VBI-S, an Injectable Fluid for the Treatment of Patients with Severe Septic Shock
Vivacelle Bio, Inc. announced that it supported an investigational new drug (IND) application to the U.S. Food & Drug Administration for a phase IIa clinical trial of VBI-S, a phospholipid-based nanoparticle fluid that has the potential to elevate the blood pressure of patients who are suffering severe septic shock.
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BIOSIGHT, LTD: Receives Orphan Drug Designation From the FDA for BST-236 for the Treatment of Acute Myeloid Leukemia
Biosight Ltd., a pharmaceutical development company focused on the development of novel oncology therapeutics, announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to BST-236, an investigational novel antimetabolite, for the treatment of acute myeloid leukemia (AML).
U.S. FOOD AND DRUG ADMINISTRATION: Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine
The U.S. Food and Drug Administration is warning consumers about safety concerns regarding an ingredient called vinpocetine that is found in dietary supplements, specifically concerns about the use of this ingredient by women of childbearing age.
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U.S. FOOD AND DRUG ADMINISTRATION: FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer
The U.S. Food and Drug Administration Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer.
CADENT THERAPEUTICS: Announces FDA Orphan Drug Designation for CAD-1883 for Spinocerebellar Ataxia
Cadent Therapeutics, a company focused on the development of therapies to improve the lives of patients with movement and cognitive disorders, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAD-1883, an investigational treatment for spinocerebellar ataxia (SCA), a genetic disorder characterized by progressive loss of coordination, slurred speech, difficulty controlling eye movements and cognitive dysfunction.
EPIZYME, INC.: Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma
Submission Follows Productive Pre-NDA Meeting and Marks On-time Execution of First of Two NDA Submissions Planned for 2019
ASTELLAS PHARMA, INC.: U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib)
Phase 3 ADMIRAL trial showed patients treated with XOSPATA demonstrated longer Overall Survival than those who received salvage chemotherapy
ALS patient wins battle with 'Right to Try' legislation
Amyotrophic lateral sclerosis, better known as Lou Gehrig’s disease, is an illness that has no FDA approved drug to alleviate the symptoms. In fact, it does not have a cure.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality
The U.S. Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality.
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U.S. FOOD AND DRUG ADMINISTRATION: FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
The U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant.
U.S. FOOD AND DRUG ADMINISTRATION: FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea
FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea
JOHNSON & JOHNSON: U.S. FDA Grants Priority Review of INVOKANA® (canagliflozin) sNDA 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 kidney failure when added to current standard of care
Expert says sunscreen users shouldn't be deterred
Despite a recent study which concluded that sunscreen enters the bloodstream after just one day of use, experts are urging the public to continue using sunscreen.