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Results For "US-FDA"

256 News Found

SMS Pharmaceuticals reports robust Q2FY24 operational performance
News | November 10, 2023

SMS Pharmaceuticals reports robust Q2FY24 operational performance

Q2FY24 EBITDA up by 105% y-o-y at Rs. 28 crore


Lupin Mandideep plant gets USFDA green signal
Drug Approval | November 01, 2023

Lupin Mandideep plant gets USFDA green signal

The inspection of the facility conducted from August 7 to August 11, 2023


Zhimeng Biopharma CB03 receives Orphan Drug Designation from the USFDA
Drug Approval | October 23, 2023

Zhimeng Biopharma CB03 receives Orphan Drug Designation from the USFDA

CB03 is a candidate drug for the treatment of ALS and other central nerve system (CNS) diseases


LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia
Diagnostic Center | October 23, 2023

LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia

LG Chem is making progress in the development of the world's first oral treatment for rare forms of obesity.


Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules
Drug Approval | October 20, 2023

Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules

Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)


Syngene Q2 FY23-24 revenue from operations up 18.5% to Rs 910 Cr
News | October 18, 2023

Syngene Q2 FY23-24 revenue from operations up 18.5% to Rs 910 Cr

Profit after tax (before exceptional items) up 23% to Rs 215 crores


Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart
Drug Approval | October 09, 2023

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022


Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals
News | October 03, 2023

Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals

Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company


SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance
Startup | October 03, 2023

SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance

SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology