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1115 News Found

Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19
News | October 30, 2023

Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19

The companies plan to start a pivotal Phase 3 trial in the coming months


Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer
Drug Approval | October 26, 2023

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients


USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
Drug Approval | October 26, 2023

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer


Innocan Pharma reports discovery regarding its LPD platform and global CBD research
News | October 25, 2023

Innocan Pharma reports discovery regarding its LPD platform and global CBD research

The company expects that this development could improve the strength of its application to the FDA for new drug approval


Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer
News | October 25, 2023

Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer

Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada


Zhimeng Biopharma CB03 receives Orphan Drug Designation from the USFDA
Drug Approval | October 23, 2023

Zhimeng Biopharma CB03 receives Orphan Drug Designation from the USFDA

CB03 is a candidate drug for the treatment of ALS and other central nerve system (CNS) diseases


LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia
Diagnostic Center | October 23, 2023

LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia

LG Chem is making progress in the development of the world's first oral treatment for rare forms of obesity.


FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents
Drug Approval | October 21, 2023

FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents

The vaccine further advances Pfizer’s vaccine portfolio and builds on more than 20 years of expertise and knowledge in the prevention of meningococcal disease


USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis
Drug Approval | October 20, 2023

USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis

Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials


ImmunoACT announces the approval of India's first CAR-T cell therapy 'NexCAR19'
News | October 16, 2023

ImmunoACT announces the approval of India's first CAR-T cell therapy 'NexCAR19'

NexCAR19 is an indigenously developed CD19 targeted CAR-T cell therapy