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 ...

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

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, ...

The US drug regulator has completed a pre-approval inspection at Emcure’s Ahmedabad oncology facility without issuing a Form ...