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973 News Found

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting
Drug Approval | November 17, 2023

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer


Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer
Drug Approval | November 16, 2023

Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer

Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient


NATCO Pharma announces successful completion of USFDA inspection
Drug Approval | November 02, 2023

NATCO Pharma announces successful completion of USFDA inspection

NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023


SN Bioscience announces Phase 1 study results of SN-38 nanoparticle anti-cancer drug
Clinical Trials | October 30, 2023

SN Bioscience announces Phase 1 study results of SN-38 nanoparticle anti-cancer drug

Impressive safety and efficacy for solid cancer patients followed by global clinical study plan


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


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


Need to include ASMD as a notified condition in the National Policy for rare diseases
Policy | October 20, 2023

Need to include ASMD as a notified condition in the National Policy for rare diseases

ASMD is highly variable and the age of onset, specific symptoms and severity of the disorder can vary dramatically from one person to another


Glenmark to launch a Triple-drug FDC of Teneligliptin + Dapagliflozin + Metformin in India for Type 2 diabetes
News | October 18, 2023

Glenmark to launch a Triple-drug FDC of Teneligliptin + Dapagliflozin + Metformin in India for Type 2 diabetes

Glenmark's Zita portfolio of medicines have been benefiting around 1.75 million Type 2 diabetic patients annually