Pharmaceutical Technology16m
FDA clamps partial hold on Phase III trial of BioNTech & OncoC4’s NSCLC therapy
A partial hold was placed on the trial after results showed variance between squamous and non-squamous NSCLC patient ...
STAT3h
Former FDA lawyers join tobacco industry in ‘epic’ fight against the agency
Gorji joined DLA Piper, one of the biggest law firms in the world, as a litigation partner, adding to its FDA team, which ...
Amid backlash, FDA changes course over shortage of weight-loss drugs
The FDA said Eli Lilly’s weight-loss drugs were no longer in shortage on Oct. 2, preventing pharmacies from making cheaper ...
Amneal Pharmaceuticals Gets FDA Approval for Pyridostigmine Bromide
Amneal Pharmaceuticals said the U.S. Food and Drug Administration has approved its new drug application for its medication pyridostigmine bromide extended-release tablets. The pharmaceutical company ...
FDA asks Texas court to shut down COVID-19 vaccine records lawsuit
The U.S. Food and Drug Administration has asked a federal judge in Texas to throw out a public records lawsuit related to ...
FDA approves Astellas' gastric cancer therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...
Nationwide Antidepressant Recall Update As FDA Sets Risk Class
The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on October 10 ...
manilatimes31m
Protara Therapeutics Granted FDA Fast Track Designation for Intravenous Choline Chloride for Patients Receiving Parenteral Support
Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that the U.S. Food and Drug ...
Food Safety News8h
FDA warns foreign seafood importers about serious HACCP violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The FDA on Thursday approved an injectable drug that eased Parkinson's disease symptoms and improved motor fluctuations in ...
Pune: FDA To Conduct Special Drive To Crack Down On Adulterated Food Items During Diwali
With Diwali around the corner, the Food and Drug Administration (FDA) is increasing its vigilance and will be conducting a ...
STAT4d
The biggest challenge facing the FDA’s new Rare Disease Innovation Hub
Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting ...