-
FDA Approves Novartis Targeted Cancer Drug Against Brain Tumors
A targeted oral drug combination by Novartis won U.S. approval for use in a wide range of advanced solid tumors that are driven by a certain genetic contributor, widening the use of a novel treatment approach that is known as tumor agnostic.
-
Pressured by Patients, FDA Expected to Approve ALS Drug With Modest Data
When patients are battling a terminal illness and want access to an experimental drug, how much evidence that it works should regulators require before approval? That's the question behind many of the Food and Drug Administration's toughest decisions, including last year's...
-
FDA Approves Lynparza to Treat Early-Stage Breast Cancer
British drugmaker AstraZeneca Plc said the U.S. Food and Drug Administration approved its cancer drug, jointly developed with U.S.-based Merck & Co , as a treatment for patients with early-stage breast cancer with certain mutations. AstraZeneca said on Friday the drug,...
-
FDA Approves Two New Drugs to Treat Eczema
The U.S. Food and Drug Administration approved drugs from AbbVie Inc and Pfizer Inc for treating eczema, a skin disease, the companies said on Friday.AbbVie's Rinvoq and Pfizer's Cibinqo have been approved to treat moderate-to-severe atopic dermatitis, or eczema, in...
-
FDA Approves Twice-Yearly Injection to Lower Cholesterol
The Food and Drug Administration (FDA) recently approved a novel injectable cholesterol-lowering drug to be used as an adjunct to diet and statin medication. The Novartis drug, Leqvio, is the first small interfering RNA (siRNA) therapy to reduce LDL cholesterol, the...
-
COVID-19 Omicron Variant 'Markedly Resistant' to Vaccines, Boosters: Study
A new study authored by more than 20 scientists at Columbia and the University of Hong Kong published Wednesday says that the COVID-19 omicron variant is ''markedly resistant'' to vaccines, the New York Post reported.
-
FDA Approves Imaging Drug That Helps Surgeons Spot Ovarian Cancers
Early detection of ovarian cancer helps boost a woman's survival, and the U.S. Food and Drug Administration on Monday approved a new imaging drug that can help spot tumors during surgery. The drug, Cytalux (pafolacianine), is meant to improve a surgeon's ability to detect...
-
Virtual Reality System That Eases Back Pain Approved By FDA
A 3-D virtual reality system to treat back pain was approved by the U.S. Food and Drug Administration on Tuesday.The EaseVRx system is a prescription device for at-home use that combines cognitive behavioral therapy and other behavioral methods to treat patients 18 and...
-
Implant for Chronic Eye Disorder Wins FDA Approval
The U.S. Food and Drug Administration on Friday approved Swiss drugmaker Roche Holding AG's eye implant for a chronic disorder causing blurred vision, most patients of whom currently have to receive monthly eye injections.Roche's Susvimo, previously called port delivery...
-
US FDA Approves ChemoCentryx Drug to Treat Rare Autoimmune Disease
The U.S. Food and Drug Administration on Friday approved ChemoCentryx Inc's lead drug candidate, Avacopan, for treating a rare, fatal autoimmune disease.
-
FDA Approves 'Date Rape' Drug to Treat Rare Sleep Disorder
The drug Xywav has been approved for expanded use in adults with a rare sleep disorder called idiopathic hypersomnia, the U.S. Food and Drug Administration said Thursday. The drug has a checkered history: In the 1960s, it was given to women during childbirth to dampen their...
-
Farxiga Approved to Reduce Risk for CKD Progression
Farxiga (dapagliflozin) oral tablets are now approved for adults with chronic kidney disease at risk for disease progression, the U.S. Food and Drug Administration announced Friday. The drug is the first to be approved to reduce...
-
FDA Approves First New Children's ADHD Drug in 10 Years
The first new drug developed in over a decade for children with attention deficit hyperactivity disorder (ADHD) has been approved by the U.S. Food and Drug Administration. Qelbree, also known as viloxazine, comes in a capsule...
-
New Multiple Sclerosis Treatment Approved; Will Launch in April
Johnson & Johnson will launch its newly approved drug for adults with relapsing multiple sclerosis in the United States in early April at a similar price point to rival treatments, the company's unit said on Friday.
-
First Drug to Protect Bone Marrow During Chemo Gets Green Light
The FDA approved Cosela (trilaciclib), a drug designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy. It is the only therapy available for this. Cosela should be commercially available in early March and was created by...
-
First Treatment for Weight Management Approved for People With Rare Conditions
The U.S. Food and Drug Administration approved Imcivree (setmelanotide) for chronic weight management (weight loss and weight maintenance for at least one year) in patients six years and older with...
-
First Drug Approved to Treat Rare Genetic Disorder
The U.S. Food and Drug Administration approved the first treatment for the rare genetic disorder primary hyperoxaluria type 1 (PH1), the agency announced Monday. Oxlumo (lumasiran) is...
-
First Drug in More Than a Decade Approved to Treat Organ-Damaging Disorders
The U.S. Food and Drug Administration announced the approval of the first treatment for hypereosinophilic syndrome (HES) in more than a decade. HES is defined by the Mayo Clinic as "a group of blood disorders that occur when you have high numbers of eosinophils - white blood...
-
Opioid Approved for Use in Controlled Settings
The opioid Olinvyk (oliceridine), administered by IV, has been approved for the management of moderate-to-severe acute pain in controlled settings by the U.S. Food and Drug Administration (USFDA). Olinvyk will be used short term for adults with pain that is severe enough to...
-
First Oral Drug for Spinal Muscular Atrophy Approved
The U.S. Food and Drug Administration has approved the first oral, at-home drug for spinal muscular atrophy (SMA), the agency announced Friday.
-
Drug for Rare Muscular Dystrophy Mutation Gets Accelerated Approval
Accelerated approval has been granted to Viltepso (viltolarsen) injection for treatment of patients with Duchenne muscular dystrophy (DMD) and a mutation of the DMD gene amenable to exon 53 skipping.
-
FDA Approves Drug for Disease Affecting Optic Nerves, Spinal Cord
The U.S. Food and Drug Administration approved a drug that treats a rare autoimmune disease of the central nervous system.
-
Johnson & Johnson Spray Approved for Suicidal People
Johnson & Johnson's Spravato has been approved as the first antidepressant for actively suicidal people, as doctors are becoming increasingly concerned about Covid-19's effect on the mental health of Americans. The Food and Drug Administration approval means the quick-acting...
-
Drug to Help in Alzheimer's Battle Approved
The U.S. Food and Drug Administration has approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology.
-
Generic Asthma Inhaler Approved
The first generic albuterol inhaler in the United States was approved Wednesday by the U.S. Food and Drug Administration in response to inhaler shortages caused by the coronavirus pandemic.