In April this year, the United States Food and Drug Administration (US FDA) had conducted a current Good Manufacturing ...

Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...

For a pharmaceutical company, a clean FDA inspection report is crucial for maintaining and expanding its presence in global markets ...

Granules India's subsidiary resolves FDA observation during inspection at Virginia facility, parent company confirms in filing.

The US Food and Drug Administration (USFDA) issued a Form-483 with eight observations concerning manufacturing practices at Sun Pharma’s Halol facility in Gujarat.

According to a regulatory filing by the company, the US FDA conducted a Good Manufacturing Practices (GMP) inspection at the Halol site from June 2 to June 13, 2025.

The Inter-Ministerial Group is expected to examine the share purchase agreement (SPA) for IDBI Bank, after which it will be ...

Emcure Pharma share price rose in trade after the company announced that United States Food and Drug Administration (USFDA) ...

The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or ...

Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in approval for deramiocel. Read more on CAPR stock here.

The USFDA conducted an inspection at Unichem Laboratories Ltd's Roha API facility from 16th June 2025 to 20th June 2025 and issued a Form 483 with 3 observations.