Tag: FDA

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To Eat or Not to Eat? Miniature Livers Used in Safety Studies

Since food tasters have fallen out of fashion, scientists have had to devise new ways to check the safety of food and drugs that humans put in their mouths.  In the pharmaceutical industry for example, animals like mice and dogs are often used to predict if a drug candidate will be harmful to people.  If this seems strange to you, an unassuming Hershey bar should … Continue reading To Eat or Not to Eat? Miniature Livers Used in Safety Studies

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FDA Approves New Drug for Multiple Sclerosis

Multiple sclerosis (MS) is a neurological disease that affects over 2 million people worldwide. In patients who suffer from MS, an abnormal immune response causes damage to a fatty substance called myelin. Like the coating around an electrical wire, myelin insulates nerve cells and facilitates neural communication. Symptoms of MS include muscle weakness, fatigue, and impaired speech. On March 28th 2017, the FDA approved Ocrevus, an … Continue reading FDA Approves New Drug for Multiple Sclerosis

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Blog, Opinion

Make the FDA Great Again? Trump and the future of the drug approval process

Update: Since the writing of this article, Donald Trump has picked Scott Gottleib as FDA commissioner. -SITN editorial staff by Linda Honaker figures by Rebecca Clements Donald Trump will soon pick a new commissioner for the Federal Drug Administration (FDA). The choice will likely be someone who will try to make the administration’s drug approval requirements less rigorous in order to get drugs on the … Continue reading Make the FDA Great Again? Trump and the future of the drug approval process

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Say Goodbye to Antibacterial Soaps: Why the FDA is banning a household item

by Gabriel W. Rangel figures by Michael Gerhardt How many times per day do you wash your hands? Do you ever think about the type of soap you use? We all know handwashing with soap is an impactful way to maintain health by decreasing the risk of becoming infected with one germ or another. Therefore, using soap with antibacterial compounds added is a no-brainer, right? … Continue reading Say Goodbye to Antibacterial Soaps: Why the FDA is banning a household item

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Prescription Drug Advertisement Goes on the Walls

by Li Zha Boston, MA has a very high concentration of biopharmaceutical companies and life science research. Residents in the area are bombarded by direct-to-consumer advertising of health care services and products even during their daily commute. On an average day, commuters can expect to see ads for clinical studies of depression or anorexia, as well as drugs that have just been approved by the … Continue reading Prescription Drug Advertisement Goes on the Walls

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T Cell
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FDA suspends (and promptly restarts) clinical trial for new cancer therapy

Bringing a new medical therapy to market is rarely a straightforward task, as a biotech company called Juno Therapeutics learned firsthand.  Juno specializes in CAR-T therapy, which uses genetic engineering to teach a patient’s own immune system to destroy cancer cells. Unfortunately, 3 of the 129 patients who had received this treatment in a clinical trial recently died from excessive brain swelling, prompting the FDA to … Continue reading FDA suspends (and promptly restarts) clinical trial for new cancer therapy

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Oncolytic viruses- A one of a kind FDA approval

by Nishita Parnandi figures by Krissy Lyon One of the biggest challenges in treating cancer is to specifically target the cancerous site in a tissue without killing the surrounding normal cells. The use of oncolytic viruses is a new cancer treatment that is excellent at achieving just that. An oncolytic virus named ImlygicTM manufactured by Amgen recently received the stamp of approval from the FDA … Continue reading Oncolytic viruses- A one of a kind FDA approval

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DNA Profile
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23andMe wins approval from FDA: What does your DNA say about you?

Spitting into a plastic tube normally doesn’t cost $199, but the personal genomics company 23andMe has recently won FDA approval to turn that saliva into a DNA fingerprint.  By identifying common variants in our genetic code, 23andMe’s DNA-testing service originally supplied personalized insights into disease predisposition, drug sensitivity, and other health-related traits.  In 2013, however, the FDA demanded that 23andMe shutter the health-related aspect of … Continue reading 23andMe wins approval from FDA: What does your DNA say about you?

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Printing Pills: FDA Approves First 3-D Printed Drug

Additive manufacturing – colloquially known as 3-D printing – can generate complex objects like firearms and human organs, but its latest technical milestone revolves around something much more unassuming: a pill.  Earlier this month, the FDA approved an anti-epileptic drug called Spritam that has the same active ingredient (levetiracetam) as a drug that was approved in 1999.  So why is this noteworthy?  It turns out … Continue reading Printing Pills: FDA Approves First 3-D Printed Drug

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