Food and Drug Administration News

Carcinogen Worry Causes Generic Zantac Recall at U.S. Pharmacies

Some generic Zantac is being pulled from major chain pharmacies in the U.S. shortly after French officials recalled all versions of the popular stomach drug amid a global investigation into a carcinogen found in the pills. Canadian drugmaker Apotex Inc. …

Carcinogen in Zantac and Its Generics Triggers Probes by FDA, EU

Global health regulators sounded a coordinated alarm about the possibility that a stomach drug taken by millions of people could be tainted with the same cancer-causing agent that has sparked a worldwide recall of blood-pressure pills. Drug-safety officials in the …

Drugmaker Insys Wins Bankruptcy Court Approval to Sell Off Opioid

Drugmaker Insys Therapeutics Inc on Thursday won court approval to sell its flagship fentanyl spray to a buyer who agreed to only market the drug for use by cancer patients, in response to concerns about the product’s role in fueling …

FDA Proposes Graphic Warnings on Cigarette Packs, Advertisements

The U.S. Food and Drug Administration has proposed that cigarette packs carry graphic new health warnings including pictures and text outlining lesser-known risks of smoking like bladder cancer and diabetes as well as lung cancer. The FDA said the proposed …

Novartis Drug Data Allegations Revive Questions Over Ethics

Concern over Novartis AG’s corporate culture returned to the spotlight after U.S. regulators said the Swiss drugmaker delayed disclosing manipulation of animal testing data for the world’s most expensive drug. The company became aware of a data problem on March …

Allergan Stop Selling Some Breast Implants After Cancer Tie

Allergan Plc will stop selling some breast implants after the U.S. Food and Drug Administration said that textured implants had been associated with a rare type of blood cancer. Allergan’s textured Biocell saline-filled and silicone-filled breast implants and tissue expanders …

FDA Targets Curaleaf in Crackdown on CBD Marketing

The most valuable marijuana company in the U.S. is under fire for how it’s marketing and selling CBD, the trendy cannabis extract now sold at national retailers. The Food and Drug Administration sent Curaleaf Holdings Inc. President Joseph Lusardi a …

Quality Failures at Generic Drug Maker Put Patients at Risk, FDA Warns

Manufacturing problems at Akorn Inc.’s New Jersey plant “pose a risk to patients,” U.S. regulators have warned the embattled generic-drug maker, which blew a $4.3 billion takeover deal with Fresenius SE two years ago over similar allegations. In a warning …

Dairy Industry Wants You to Know Vegan ‘Butter’ Isn’t Actual Butter

Miyoko Schinner is a perfect illustration of the American dream. To the U.S. dairy industry, however, she is something altogether different. A Japanese immigrant, Schinner started a small company that blossomed into a wildly successful vegan cheese maker, one with …

J&J ‘Did Everything’ to Push Opioids, Oklahoma Witness Says

Oklahoma’s star witness told a state judge that Johnson & Johnson pressed doctors to prescribe its painkillers even as the potentially fatal addictive threat posed by the drugs became clear more than a decade ago. The judge, Thad Balkman, is …