Us Fda News

The US FDA has approved AstraZeneca's new breast cancer pill, Etcamah (camizestrant), for use in combination with other medicines for patients with a geneticall

The US Food and Drug Administration (FDA) has approved Rasonque (daraxonrasib), a new drug for advanced pancreatic cancer. This approval marks a significant dev

The US FDA has approved a new drug for pancreatic cancer that shows potential to extend patient survival.

Lannett's Seymour manufacturing facility, an arm of Aurobindo, received four observations from the U.S. FDA.

Pharma stocks, specifically Caplin Point and Natco Pharma, are under scrutiny following U.S. FDA inspections that resulted in observations at their facilities.

Aurobindo Pharma's Raleigh manufacturing plant in the US has received a 'Voluntary Action Indicated' (VAI) classification from the US FDA, allowing applications

The U.S. FDA has issued a warning letter to Eugia Pharma, a subsidiary of Aurobindo Pharma, following earlier observations and an Official Action Indicated (OAI

Lupin Limited has launched its Sugammadex Injection in the United States after receiving approval from the US Food and Drug Administration. The company claims i

Dr. Reddy's Srikakulam facility received three observations from the U.S. FDA following a Pre-Approval Inspection and Good Manufacturing Practices inspection at

Alembic Pharma has received approval from the U.S. FDA for its generic drug used to treat chronic constipation.

The US FDA has approved the first pill designed to replace injections for fighting high cholesterol.

The US FDA has approved the world's first oral PCSK9 inhibitor, a new cholesterol-lowering pill offering a convenient alternative to injections for adults with

A clinical investigator associated with a study at Alembic's bioequivalence unit has received a warning letter from the U.S. FDA.