All of us have probably had the experience of browsing the aisles at the grocery store looking for healthy foods to take home for our families.  A few foods we find may include the word “healthy” on ...

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...

The inspection was completed on 10 April 2025 and at the conclusion, the USFDA issued a Form 483 with 11 observations. These observations are procedural in nature. Disclaimer: No Business Standard ...

Aurobindo Pharma received a Form 483 with 11 observations from the USFDA for its Raleigh plant in North Carolina. The company ...

Exelixis, Inc. EXEL announced that the FDA has approved the label expansion of its lead drug Cabometyx (cabozantinib). The regulatory body approved Cabometyx for the treatment of adult and ...

Granules Pharma Inc, which is an FDA and DEA-approved facility and known ... after getting six Form 483 observations following an inspection in September 2024. According to Granules India, it ...

The Company and the FDA reached foundational alignment on the overall study design for a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial, including proposed AD patient ...

Among the string of recalls, the FDA had determined last year that more than 50 million potassium chloride extended-release capsules had the potential to kill U.S. patients. Still, ProPublica ...

Zydus Lifesciences said that it has received final approval from the United States Food and Drug Administration (US FDA) to manufacture Apalutamide ... The group now has 420 approvals and has so far ...