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8409 News Found

Eplontersen granted Orphan Drug Designation in the US
Biotech | January 24, 2022

Eplontersen granted Orphan Drug Designation in the US

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US


Omicron is now in community transmission in India: INSACOG
News | January 23, 2022

Omicron is now in community transmission in India: INSACOG

The country is sixth among the most affected countries by active cases


Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward


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


Lannett receives USFDA safety review for biosimilar insulin glargine
Biotech | January 22, 2022

Lannett receives USFDA safety review for biosimilar insulin glargine

Go-ahead for pivotal clinical trial which is expected to commence by March


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


Molnupiravir reduces risk of hospitalisation by 30% : Dr Shashank Joshi
News | January 22, 2022

Molnupiravir reduces risk of hospitalisation by 30% : Dr Shashank Joshi

Omicron patients below 60 with no comorbidities can start treatment with paracetamol


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


Sputnik V demonstrates better protection compared to Pfizer against Omicron: Study
News | January 21, 2022

Sputnik V demonstrates better protection compared to Pfizer against Omicron: Study

An article by a team of 12 Italian and 9 Russian scientists led by Francesco Vaia, Director of the Spallanzani Institute and Alexander Gintsburg, Director of the Gamaleya Center, has been published in medRxiv


Bristol Myers Squibb receives approval for Abecma in Japan
Drug Approval | January 21, 2022

Bristol Myers Squibb receives approval for Abecma in Japan

It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan