The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in ...

It’s time to revamp the FDA’s “generally recognized as safe,” or GRAS, program that allows companies to add untested ...

DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.

Roughly a year after receiving an FDA reprimand at its manufacturing plant in Michigan, Indian drugmaker Piramal Pharma has ...

A new study from researchers at Boston University found microplastics may play a role in the spread of drug-resistant ...

There's rosemary, that's for remembrance,' says Ophelia in Shakespeare's Hamlet. So it is fitting that researchers would study a compound found in rosemary and sage -- carnosic acid -- for its impact ...

New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like irregular heart rhythm or sleep apnea alerts. They are usually labeled as such.

The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA). The new tablet is ...

If you have a complaint about a product regulated by the U.S. Food and Drug Administration (FDA), the agency wants to hear about it.

Indoco Remedies declined 3.22% to Rs 224.20 after its Clinical Research Organization, AnaCipher, located in Hyderabad, received one Form 483 from the United States Food and Drug Administration (US FDA ...