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1785 News Found

USFDA accepts dupilumab for priority review in adults with prurigo nodularis
Drug Approval | June 01, 2022

USFDA accepts dupilumab for priority review in adults with prurigo nodularis

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved


US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027
Drug Approval | June 01, 2022

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study


CEPI partners with Bharat Biotech, Unversity of Sydney and ExcellGene to develop variant proof Covid-19 vaccine
Biotech | May 10, 2022

CEPI partners with Bharat Biotech, Unversity of Sydney and ExcellGene to develop variant proof Covid-19 vaccine

CEPI will provide funding of up to US $19.3 million to support the development of a ‘variant-proof’ SARS-CoV-2 vaccine candidate to an international multidisciplinary consortium


Shilpa Medicare receives NoC for biosimilar Aflibercept
Biotech | April 25, 2022

Shilpa Medicare receives NoC for biosimilar Aflibercept

Aflibercept is the second biosimilar product that has entered the clinical trial phase after biosimilar Adalimumab


BioPharma’s Herceptin biosimilar Phase 3 results positive
Biotech | March 12, 2022

BioPharma’s Herceptin biosimilar Phase 3 results positive

The study met its primary endpoint and showed equivalent efficacy and a comparable safety profile


Avenge Bio announces peer-reviewed publication on preclinical proof of concept for LOCOcyte platform technology
Biotech | March 03, 2022

Avenge Bio announces peer-reviewed publication on preclinical proof of concept for LOCOcyte platform technology

Ovarian cancer is one of the most difficult cancers to treat. It is typically not detected until later stages, and about 70 percent of patients will have recurrence after an initial treatment, which is often fatal


China’s NMPA accepts supplemental NDA for Carteyva
Drug Approval | February 28, 2022

China’s NMPA accepts supplemental NDA for Carteyva

The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China


Study details Proof-of-Concept for Covid-19 detection via saliva screening
Medical Device | February 24, 2022

Study details Proof-of-Concept for Covid-19 detection via saliva screening

Methodology developed by QIMR Berghofer researchers utilizing the Agilent Cary 630 FTIR


USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
Drug Approval | February 18, 2022

USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib

The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022


USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi
Biotech | February 17, 2022

USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi

Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years