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Results For "phase-3"

732 News Found

DGCI green lights Biological E for Phase 2/3 trials of its Covid-19 vaccine candidate for children
Biotech | September 03, 2021

DGCI green lights Biological E for Phase 2/3 trials of its Covid-19 vaccine candidate for children

The trial will be conducted across 10 sites in India


Janssen announces U.S. FDA approval of Invega Hafyera
Drug Approval | September 02, 2021

Janssen announces U.S. FDA approval of Invega Hafyera

Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months


Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis
Biotech | August 31, 2021

Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis

Results reinforce the well-established safety profile of Dupixent - the first-ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old


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


Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.


Moderna to set up mRNA manufacturing in Canada
Biotech | August 11, 2021

Moderna to set up mRNA manufacturing in Canada

The collaboration will support Canada with direct access to rapid pandemic response capabilities


GW Pharmaceuticals receives approval for Epidyolex to treat seizures
Drug Approval | August 11, 2021

GW Pharmaceuticals receives approval for Epidyolex to treat seizures

TSC causes epilepsy in up to 85 % of patients, and up to 60 % of those patients do not respond to standard anti-seizure medicines


INNOVIO QoQ revenues down for the period ended June 30, 2021
Biotech | August 10, 2021

INNOVIO QoQ revenues down for the period ended June 30, 2021

Company working on COVID vaccine INO 4800


NRx Pharmaceuticals announces initiation of Phase 2b trial of BriLife vaccine for Covid-19
Drug Approval | August 10, 2021

NRx Pharmaceuticals announces initiation of Phase 2b trial of BriLife vaccine for Covid-19

Preclinical and early human data indicate BriLife may confer enhanced immunity against Delta variant