FDA: Recall of heart, blood pressure medication grows due to cancer concerns

FDA: Recall of heart, blood pressure medication grows due to cancer concerns

The U.S. Food and Drug Administration last week expanded the list of medications under recall because of a chemical impurity that could put patients at risk of getting cancer. >> Read more trending news Officials with the FDA announced Friday that Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of its valsartan/amlodipine/hydrochlorothiazide tablets after trace […]

FDA extends certain EpiPen expiration dates to combat shortage

FDA extends certain EpiPen expiration dates to combat shortage

EpiPens typically have a shelf life of 20 months, according to the FDA, which said it’s allowing the additional four months after reviewing stability data provided by Mylan. The move comes as parents of children with allergies are finding EpiPens hard to come by in pharmacies as they stock up for back-to-school season. “We are […]

Landmark FDA Approval Brings Powerful Gene Silencing Method to Market

Landmark FDA Approval Brings Powerful Gene Silencing Method to Market

Earlier this month, the FDA approved an entirely new family of drugs, one so powerful that it could put CRISPR-based gene therapy to shame. Backed by two decades of research and a Nobel Prize, these drugs have the ability to cure inherited diseases—and do so without actually needing to edit the delicate genome. The green-lit […]

FDA Analysis Shows Similar Success Rates for Pediatric Trials Using Clinical and Surrogate Endpoints

FDA Analysis Shows Similar Success Rates for Pediatric Trials Using Clinical and Surrogate Endpoints

An analysis by US Food and Drug Administration (FDA) officials published earlier this month finds that there is a similar success rate for pediatric pivotal trials relying on surrogate endpoints compared to trials that use clinical endpoints. While the authors find the use of surrogate endpoints in pediatric trials is effective, they argue that it […]

FDA kicks off effort to examine importing drugs

FDA kicks off effort to examine importing drugs

W ASHINGTON — A controversial Food and Drug Administration working group has begun discussing how to import drugs from other countries as a way of bringing down prices for American patients, a top Trump administration health official said Monday. “That work group has met and is outlining its plan of action,” Dan Best, senior adviser […]

FDA Tries To Stop People From Abusing Their Pets' Opioids

FDA Tries To Stop People From Abusing Their Pets' Opioids

NASHVILLE, Tenn. – The U.S. Food and Drug Administration issued new guidelines for veterinarians to help curb the common problem of pet owners using their animals to get opioids. While opioids are a small part of the veterinarian’s medical arsenal, they are still a critical part of treating pain in animals. Many veterinarians across the […]

FDA to approve first natural cannabis drug to fight seizures

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Janssen, Lundbeck and Takeda Raise Issues With FDA Draft Guidance on MDD Drugs

Janssen, Lundbeck and Takeda Raise Issues With FDA Draft Guidance on MDD Drugs

Posted 20 August 2018 | By Zachary Brennan  Three drugmakers have raised questions with the US Food and Drug Administration’s (FDA) draft guidance on developing major depressive disorder (MDD) treatments. Lundbeck used its comments to urge FDA to refrain from classifying antidepressants based on the timing of their onset of effect. Instead, Lundbeck said it […]

FDA Grants Orphan Drug Designation to Bertilimumab for Treatment of Bullous Pemphigoid

FDA Grants Orphan Drug Designation to Bertilimumab for Treatment of Bullous Pemphigoid

This morning, August 20, 2018, the US Food and Drug Administration (FDA) granted an orphan drug designation to Immune Pharmaceuticals, Inc.’s bertilimumab for the treatment of bullous pemphigoid, a rare autoimmune, chronic skin disorder. “We are incredibly gratified that bertilimumab has received an orphan drug designation for the treatment of bullous pemphigoid from the FDA […]

FDA: Thyroid Medications Recalled Due to Inconsistent Potency

FDA: Thyroid Medications Recalled Due to Inconsistent Potency

Lab tests confirmed Sichuan Friendly API had inconsistent levels of levothyroxine and liothyronine Westminster Pharmaceuticals announced a recall of all lots of Levothyroxine and Liothyronine (Thyroid Tablets) 15mg, 30mg, 60mg, 90mg, 120mg as the product was manufactured using active pharmaceutical ingredients (API) from a company that was found to have deviated from the Food and […]