In a regulatory filing made during market hours today, Natco Pharma announced that it has received an establishment ...

Q1FY26 revenues at ?12.7 billion, YoY growth of 142% and flat QoQ growth. This includes revenues from the acquired NRT business.

Dr Reddy's Laboratories received a Form 483 with seven observations from the USFDA for its Srikakulam-based plant in Andhra ...

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

Emcure Pharma gets two observations for API plant from USFDA “We are addressing the observations comprehensively,” the company said.

Gland Pharma Ltd. said on Tuesday that the US Food and Drug Administration has issued a Form 483 with three observations to its facility in Visakhapatnam. According to the company’s exchange filing, ...

USFDA issues Form 483 with 3 three observations to Gland Pharma's Visakhapatnam unit As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of ...

On Friday, BTIG reaffirmed its Buy rating and $10.00 stock price target for Humacyte (NASDAQ:HUMA) following the release of a Form 483 from the FDA.

API manufacturer Global Calcium has been struck with a Form 483 filing following an FDA inspection of its factory in India.

Importantly, FDA also states that timely Form FDA 483 responses that include “appropriate corrective and preventive actions could impact FDA’s determination of the need for subsequent Agency ...