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927 News Found

European Commission approves Merck’s KEYTRUDA as adjuvant therapy for RCC
Drug Approval | January 28, 2022

European Commission approves Merck’s KEYTRUDA as adjuvant therapy for RCC

KEYTRUDA is now approved as monotherapy for adults with Renal Cell Carcinoma (RCC)


Lupin signs promotional agreement with Exeltis on SOLOSEC
News | January 28, 2022

Lupin signs promotional agreement with Exeltis on SOLOSEC

SOLOSEC is designed to be easy to take and one oral dose contains a complete course of treatment


Moderna working on Omicron-specific booster candidate
News | January 27, 2022

Moderna working on Omicron-specific booster candidate

This will evaluate the immunogenicity, safety, and reactogenicity of a single booster dose in adults aged 18 years and older


Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy
Drug Approval | January 26, 2022

Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy

Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date


USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant


Pfizer and BioNTech evaluate Omicron specific Covid-19 vaccine
News | January 25, 2022

Pfizer and BioNTech evaluate Omicron specific Covid-19 vaccine

First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose


USFDA expands use of Remdesivir  for Covid-19
News | January 22, 2022

USFDA expands use of Remdesivir for Covid-19

Previously, the use of the drug was limited to patients requiring hospitalization


Positive top-line results for bimekizumab in second phase 3 psoriatic arthritis study
Biotech | January 22, 2022

Positive top-line results for bimekizumab in second phase 3 psoriatic arthritis study

UCB plans to submit regulatory applications in Q3 2022


US FDA approves Idorsia’s insomnia drug
Drug Approval | January 21, 2022

US FDA approves Idorsia’s insomnia drug

Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain


Zydus receives final approval from USFDA for Vigabatrin tablets
Drug Approval | January 20, 2022

Zydus receives final approval from USFDA for Vigabatrin tablets

Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain