The FDA has found problems at an Indian factory that makes generic drugs for American patients, including one medication that ...

Alnylam's Amvuttra enters ATTR-CM drug race, and Expedition Therapeutics seeks to bring Chinese drugs to the U.S.

The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant ...

Advancing pipeline of inhaled treprostinil products in clinical studies Strengthened financial position by up to $100 million via amendment to existing financing agreement with HealthCare Royalty ...

BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study ...

RedHill plans to submit UK MAA1 for Talicia for H. pylori infection, using MHRA's2 new fast-track approval process, referencing FDA approval, with potential UK approval ...

The inspection was completed with no 483 observations, demonstrating total compliance with the USFDA standards.

Inspection occurred from March 10, 2025 to March 14, 2025 and ended with no observations with full compliance.

Pharmaceutical company Alkem Laboratories Ltd on Thursday (March 13) announced that the United States Food and Drug ...

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

The filing further read the company will provide a comprehensive response to US FDA for the observations within the ...

A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable." Dexcom manufactures its products at its headquarters in San Diego, California and at ...