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1435 News Found

Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation
Drug Approval | August 03, 2023

Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation

Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.


Concord Biotech’s IPO to open on 4th August, 2023
News | August 01, 2023

Concord Biotech’s IPO to open on 4th August, 2023

The company through its IPO will fetch Rs 1475.26 crore - Rs 1550.59 crore at the lower and upper end of the price band.


Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Drug Approval | August 01, 2023

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy


Eugia Pharma receives USFDA approval for Plerixafor Injection
Drug Approval | July 26, 2023

Eugia Pharma receives USFDA approval for Plerixafor Injection

The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023


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


Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826
News | July 21, 2023

Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826

The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023


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


PredOmix, Core Diagnostics partner to launch OncoVeryx-F
Clinical Trials | July 18, 2023

PredOmix, Core Diagnostics partner to launch OncoVeryx-F

OncoVeryx-F, a proprietary test developed by PredOmix, is set to transform early-stage cancer detection


Moderna announces regulatory submissions for its RSV vaccine
News | July 10, 2023

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia