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.
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FDA warns homeopathic manufacturers about false labeling
Five companies with products considered homeopathic have been found to be in violation of the FDA’s current good manufacturing practice regulations.
New blood thinner approved for pediatric patients
An anticoagulant injection, Fragmin, was approved by the Food and Drug Administration last week for pediatric patients.
Doctors support FDA in its claim against 'worthless,' 'hocus pocus' homeopathic drugs
The U.S. Food and Drug Administration sent letters to companies that produce homeopathic products claiming they were in violation of current good manufacturing practice (CGMP) regulations.
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
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MAYNE PHARMA: FDA Approves SORILUX(R) for Adolescent Plaque Psoriasis
Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved SORILUX® (calcipotriene) Foam, 0.005% in adolescents.
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
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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.
FDA Update: April 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 U.S. Food and Drug Administration.
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.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first PI3K inhibitor for breast cancer
The U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.
Pharmacology expert says FDA needs to have more oversight over homeopathic products
The U.S. Food and Drug Administration recently sent letters to companies that produce homeopathic products claiming they were in violation of current good manufacturing practice (CGMP) regulations.
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.
NOVARTIS PHARMACEUTICALS: AveXis receives FDA approval for Zolgensma®, the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA)
SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis and, when left untreated in its most severe form, permanent ventilation or death for most patients by age 2[1,2]
ALLERGAN PLC: Allergan and Gedeon Richter Receive U.S. FDA Approval For Expanded Use of VRAYLAR® (cariprazine) in the Treatment of Bipolar Depression
New Indication Makes VRAYLAR First and Only Dopamine and Serotonin Partial Agonist to Treat the Full Spectrum of Bipolar I Symptoms in Manic, Mixed, and Depressive Episodes
TRUE DIAGNOSTICS, INC.: Receives FDA 510(k) Clearance to Market VeriClear™ Digital Test Device for Early Result Pregnancy
True Diagnostics, Inc. (True), a leading company for Point of Care Answers, announced that its VeriClear™ Digital Early Result Pregnancy Test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for detecting human chorionic gonadotropin (hCG) levels in women prior to their first missed period.
BIOTHERYX, INC.: Announces FDA approval of IND Application to Initiate Phase I Clinical Trial in Relapsed or Refractory Acute Myeloid Leukemia
Expects Enrollment of Phase I Trial to Begin in the Third Quarter of 2019
BAYER: Receives U.S. FDA Breakthrough Therapy Designation for Aliqopa™ (copanlisib) for the Treatment of Marginal Zone Lymphoma
U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Aliqopa based on follow-up data from the pivotal Phase II CHRONOS-1 study