GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia

Decision on EU marketing authorisation expected for momelotinib by early 2024

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer

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

Ojjaara approved in the US as the first and only treatment for myelofibrosis patients with anaemia

Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy

Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets

Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

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

Syngene Q1 FY 2024 revenue up 26% to Rs. 832 crores, PAT up 26% to Rs.93 Cr

Acquisition of biologics manufacturing facility in Bangalore to complete by the end of the third quarter in FY 24

GSK receives USFDA Fast Track designation for investigational vaccine against gonorrhoea

Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities