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4174 News Found

European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


Wockhardt and Jemincare partner for novel respiratory antibiotic Nafithromycin
Drug Approval | August 26, 2021

Wockhardt and Jemincare partner for novel respiratory antibiotic Nafithromycin

The company to receive upfront and milestone payments, in addition to royalties


RedHill Biopharma's Opaganib demonstrates strong inhibition of COVID-19 Delta variant
Drug Approval | August 26, 2021

RedHill Biopharma's Opaganib demonstrates strong inhibition of COVID-19 Delta variant

Opaganib, a leading novel small molecule investigational oral pill in development for Covid-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of the disease


Cipla forms JV with Kemwell Biopharma
News | August 25, 2021

Cipla forms JV with Kemwell Biopharma

The agreement is to develop, manufacture and commercialise biosimilars for the global market.


Xybion releases Pristima XD digital pathology
Digitisation | August 24, 2021

Xybion releases Pristima XD digital pathology

The module offers the first preclinical laboratory information system of its kind that is fully integrated into the digital pathology workflow and provides efficient pathological studies of whole slides


Delfi liquid biopsy shows promise for reducing lung cancer deaths
Biotech | August 23, 2021

Delfi liquid biopsy shows promise for reducing lung cancer deaths

When the Delfi technology was used as a pre-screen to determine if a low dose CT (LDCT), should be performed, the combined approach led to the detection of 90% of lung cancers, including 80% of stage I cancers


USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine
News | August 23, 2021

USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine

The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease


Enzene Biosciences obtains DCGI approval for Romiplostim biosimilar
Biotech | August 20, 2021

Enzene Biosciences obtains DCGI approval for Romiplostim biosimilar

It is the only biopharmaceutical company in India to offer all three dosage strengths of the drug (125mcg, 250mcg, and 500mcg)


Semglee approval to provide huge opportunities in the US insulin biosimilar market
Biotech | August 19, 2021

Semglee approval to provide huge opportunities in the US insulin biosimilar market

FDA approval of the first interchangeable biosimilar insulin will drive the US Insulin biosimilar market, says Kuick Research.