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3524 News Found

Aptar Pharma completes Phase I global injectables expansion program
News | November 01, 2022

Aptar Pharma completes Phase I global injectables expansion program

The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.


Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP
Drug Approval | November 01, 2022

Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP

This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.


USFDA determines inspection classification of Jubilant Pharmova's Roorkee facility
News | October 31, 2022

USFDA determines inspection classification of Jubilant Pharmova's Roorkee facility

The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue


21.4 lakh TB cases notified in India in 2021
Policy | October 30, 2022

21.4 lakh TB cases notified in India in 2021

Indigenously-developed molecular diagnostics have helped expand the reach of diagnosis to every part of the country today


Camizestrant significantly improved PFS vs. Faslodex in SERENA-2 Phase II trial
Clinical Trials | October 27, 2022

Camizestrant significantly improved PFS vs. Faslodex in SERENA-2 Phase II trial

Results reinforce commitment to next-generation oral SERD development programme


USFDA approves Imjudo in combination with Imfinzi for liver cancer
Drug Approval | October 26, 2022

USFDA approves Imjudo in combination with Imfinzi for liver cancer

Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib


AstraZeneca updates on the MESSINA Phase III trial for Fasenra in eosinophilic esophagitis
Clinical Trials | October 26, 2022

AstraZeneca updates on the MESSINA Phase III trial for Fasenra in eosinophilic esophagitis

High-level results from the MESSINA Phase III trial showed that AstraZeneca's Fasenra (benralizumab) did not meet one of the two dual-primary endpoints.


CEPI and SK bioscience partner to advance mRNA vaccine technology
News | October 26, 2022

CEPI and SK bioscience partner to advance mRNA vaccine technology

CEPI will provide up to US$40 million in initial funding to support the development of mRNA-vaccine candidates against Lassa Fever virus


Quizartinib granted priority review in the U.S.
Drug Approval | October 26, 2022

Quizartinib granted priority review in the U.S.

Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone


Lupin launches Paliperidone Extended-Release Tablets in US
News | October 24, 2022

Lupin launches Paliperidone Extended-Release Tablets in US

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 112 million in the U.S. (IQVIA MAT August 2022).