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8054 News Found

Lupin receives approval from TGA Australia for Tiotropium Dry Powder
Drug Approval | July 26, 2023

Lupin receives approval from TGA Australia for Tiotropium Dry Powder

Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsule


NATCO files generic Erdafitinib Tablets in USA
Drug Approval | July 26, 2023

NATCO files generic Erdafitinib Tablets in USA

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma


Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village
Drug Approval | July 24, 2023

Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village

Aurobindo will respond to the US FDA within the stipulated timelines


USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia
Drug Approval | July 24, 2023

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories


Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets
Drug Approval | July 24, 2023

Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets

This product would be manufactured at Lupin's Nagpur facility in India


Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction
Drug Approval | July 22, 2023

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU


Boehringer Ingelheim receives FDA approval for NexGard Plus
News | July 22, 2023

Boehringer Ingelheim receives FDA approval for NexGard Plus

The maker of ivermectin/pyrantel, the #1 vet-recommended and #1 dog-preferred real beef chew introduces the latest innovation in its portfolio


Glenmark Life Sciences reports robust 25% EBITDA growth in Q1FY24
News | July 22, 2023

Glenmark Life Sciences reports robust 25% EBITDA growth in Q1FY24

The net profit in the June quarter was also lower than Rs 146.3 crore reported in the March quarter.


Healthcare Triangle awarded contract expansion with Fortune 500 biopharmaceutical customer
Digitisation | July 20, 2023

Healthcare Triangle awarded contract expansion with Fortune 500 biopharmaceutical customer

The agreement extends the customer's suite of cloud DevOps, data engineering, and data platform management solutions