NATCO Pharma announces successful completion of USFDA inspection

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

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

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

Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur

The company is confident of addressing all the observations within the stipulated time

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

Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs

Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months

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

Syngene Q2 FY23-24 revenue from operations up 18.5% to Rs 910 Cr

Profit after tax (before exceptional items) up 23% to Rs 215 crores

USFDA inspection at Biocon Biologics' manufacturing facility in Johor, Malaysia