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

Dr. Makary joined NewsNation to discuss his first 100 days FDA Commissioner: 'People forget that the ‘F’ in FDA stands for food' FDA focused on fighting childhood obesity and diabetes As part of the ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...

Pune: Emcure Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded a Pre-Approval ...

Shares of firms like TCS, Akzo Nobel, Emcure Pharma, Adani Ent, Tata Technologies, and others will be in focus on Thursday's ...

The US FDA had conducted Pre-Approval Inspection of Emcure Pharmaceuticals Limited's manufacturing facility (Oncology) located at G.I.D.C., Taluka - Sanand, Ahmedabad - 382110, Gujarat, from June 30, ...

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

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

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

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.