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646 News Found

EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema
Drug Approval | August 21, 2023

EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema

LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment


USFDA completes PAD E inspection of Marksans' Goa facility
Drug Approval | August 09, 2023

USFDA completes PAD E inspection of Marksans' Goa facility

The inspection was conducted at its Goa, Vema manufacturing facility


Venus Remedies oncology wing product registrations go up to 506 with marketing approvals from 4 more countries
News | August 01, 2023

Venus Remedies oncology wing product registrations go up to 506 with marketing approvals from 4 more countries

The company has secured 506 marketing approvals for its oncology products across 76 countries.


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


Adlib and Generis launch software connector to increases automation and compliant management of document repositories
Digitisation | July 26, 2023

Adlib and Generis launch software connector to increases automation and compliant management of document repositories

CARA is a data and content management platform that helps companies in regulated industries such as finance, energy, and manufacturing transform their complex business processes


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


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


Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin
News | July 22, 2023

Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin

Good momentum in commercial CDMO business