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525 News Found

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


Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster
Clinical Trials | November 21, 2022

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster

Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data


Eugia Pharma receives USFDA approval for Amphotericin B Liposome for Injection
Drug Approval | November 19, 2022

Eugia Pharma receives USFDA approval for Amphotericin B Liposome for Injection

The product is expected to be launched by Q4 FY23.


Apollo launches national program to promote rational use of antibiotics
News | November 18, 2022

Apollo launches national program to promote rational use of antibiotics

Program will fight the rising incidence of antimicrobial (drug) resistance and improve patient outcomes


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.


LANXESS to showcase Biosecurity Solutions at EuroTier 2022
News | November 10, 2022

LANXESS to showcase Biosecurity Solutions at EuroTier 2022

The core of “LANXESS Biosecurity Solutions” is a portfolio of scientifically formulated, highly effective and versatile biocidal products


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


Zydus receives final approval from USFDA for Micafungin for Injection
Drug Approval | October 26, 2022

Zydus receives final approval from USFDA for Micafungin for Injection

Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data


Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation
Clinical Trials | October 23, 2022

Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation

Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint


Mandaviya directs officials to focus on strengthening genome sequencing for early detection of variants
News | October 19, 2022

Mandaviya directs officials to focus on strengthening genome sequencing for early detection of variants

He also highlighted the need for community awareness for continued implementation of the Covid Appropriate Behaviour (CAB) especially in view of the upcoming festival season