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Results For "US-FDA"

423 News Found

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


Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients


Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma
News | September 08, 2023

Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma

Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.


Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million
News | September 02, 2023

Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million

The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year