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Results For "approval"

2477 News Found

Biosergen, Alkem collaborate to develop anti-infective for severe fungal infections
News | September 26, 2023

Biosergen, Alkem collaborate to develop anti-infective for severe fungal infections

Biosergen AB is developing BSG005 for the treatment of severe and difficult-to-treat invasive fungal diseases


Glenmark Pharma to sell 75% stake in Glenmark Life Sciences to Nirma for Rs. 5,652 Cr
News | September 22, 2023

Glenmark Pharma to sell 75% stake in Glenmark Life Sciences to Nirma for Rs. 5,652 Cr

Will continue to own a 7.84 per cent stake in Glenmark Life Sciences with the stake reduction


USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA
Drug Approval | September 21, 2023

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483


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


Ojjaara approved in the US as the first and only treatment for myelofibrosis patients with anaemia
Drug Approval | September 19, 2023

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


Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for  cell lung cancer
Drug Approval | September 18, 2023

Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for cell lung cancer

Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial


Cabinet approves foreign investment of up to Rs. 9,589 crore in Suven Pharmaceuticals
Policy | September 14, 2023

Cabinet approves foreign investment of up to Rs. 9,589 crore in Suven Pharmaceuticals

The approval is for acquisition of up to 76.1% equity shares of Suven Pharmaceuticals by Berhyanda Limited


Bajaj Healthcare announces receipt of EIR from USFDA
Drug Approval | September 14, 2023

Bajaj Healthcare announces receipt of EIR from USFDA

The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations


AI to transform all processes in drug development by 2026, predicts CPHI Report
Digitisation | September 13, 2023

AI to transform all processes in drug development by 2026, predicts CPHI Report

In 2030 over 50% of FDA approvals will involve AI discovered and developed drugs


Biocon Biologics completes integration of Viatris Biosimilars’ business in North America
News | September 07, 2023

Biocon Biologics completes integration of Viatris Biosimilars’ business in North America

Biocon Biologics recently acquired the global biosimilars business of its long-term partner Viatris