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5475 News Found

Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21
News | December 01, 2022

Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21

QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.


Sanofi, GSK’s next-generation COVID-19 booster vaccine approved by the European Commission
Drug Approval | November 11, 2022

Sanofi, GSK’s next-generation COVID-19 booster vaccine approved by the European Commission

First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster
Drug Approval | November 11, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster

The European Commission will review the CHMP recommendation and is expected to make a final decision soon.


GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Drug Approval | November 03, 2022

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan


Lonza and Singzyme to accelerate development of Bioconjugates
News | November 01, 2022

Lonza and Singzyme to accelerate development of Bioconjugates

Through the collaboration, Lonza will gain access to Singzyme’s enzymatic conjugation platform enabling the site-specific binding of payloads with peptidic linkers to proteins of interest


NHA organises workshop to accelerate adoption of ABDM
Policy | November 01, 2022

NHA organises workshop to accelerate adoption of ABDM

The participants discussed the latest developments under ABDM that shall enable true interoperability in the health sector and how effective adoption of ABDM can pave the way towards Universal Health Coverage


Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program
Drug Approval | November 01, 2022

Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program

The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.


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