FDA taken to task over opioid approval process
Back in June, the U.S. Food and Drug Administration (FDA) released a draft guidance for overhauling the opioid approval process, which one member of the audience said was woefully inadequate.
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Expanded recall set for blood pressure medication Losartan
Torrent Pharmaceuticals recently announced it was expanding its recall for Losartan potassium tablets and Losartan potassium/hydrochlorothiazide tablets.
Peanut allergy treatment moves closer to FDA approval
A treatment for peanut allergies took another step toward becoming a reality as the Allergenic Products Committee voted to advise the U.S. Food and Drug Administration (FDA) this month during the approval process.
FDA approves treatment for rare lung disease scleroderma
The treatment involves taking Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, which is called SSc-ILD.
FDA confirms guidance on placebos, blinding for cancer trials
The Food and Drug Administration (FDA) made a recommendation to drugmakers last week stating that they only use placebos in cancer clinical trials in select circumstances.
FDA approves clinical trial for Sanfilippo syndrome
The Food and Drug Administration gave the go-ahead last week to accept Seelos Therapeutics’ application for a new drug to combat Sanfilippo syndrome, a rare genetic defect.
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Doctors see good things with new scoliosis treatment recently approved by FDA
A doctor based at Johns Hopkins in Baltimore sees the new treatment for scoliosis recently approved by the U.S. Food and Drug Administration as a viable option for young patients.
FDA approves new treatment for scoliosis
The U.S. Food and Drug Administration approved an innovative treatment for scoliosis last week and it happens to have a fancy nickname. It’s called The Tether and it provides a fusion-less alternative for young patients requiring surgery.
Consumers advised to research before taking CBD as FDA seeks more research
The U.S. Food and Drug Administration has set its sights on working to learn more about the safety of CBD and related products.
NACS outlines proposals to combat vape sales to minors
With the rise of e-cigarettes and other popular vape products being consumed by young people, government entities are scrambling to find a solution to address the problem.
New non-insulin treatment for type 2 diabetes approved
The Food and Drug Administration recently approved the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000.
Doctor says concern over ‘forever’ chemicals a matter of chemophobia
Jane Orient, executive director of the Association of American Physicians and Surgeons and president of Doctors for Disaster Preparedness, believes it’s the latest example of chemophobia.
Questions raised over cancer drugs in FDA's accelerated approval program
WASHINGTON -- A low percentage of cancer drugs that received accelerated Food and Drug Administration approval had positive results in the long run, according to a recent study by the Journal of the American Medical Association.
Effectiveness of fast-tracked cancer drugs questioned
Few cancer drugs that received accelerated Food and Drug Administration approval lived up to their billing, according to a JAMA study.
New added sugar labeling policy could be sweet news for FDA, consumers
The Food and Drug Administration's (FDA) recently announced a mandatory added sugar labeling policy for packaged foods and beverages, set to take effect between 2020 and 2021.
FDA approves $2.1 million drug, opens door for more gene therapy
The U.S. Food and Drug Administration recently approved a drug that costs $2.1 million and it’s a potential cure for a childhood disorder that afflicts children under 2 years of age.
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.
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.
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.