Drug Approval | November 08, 2023
Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets
This product will be manufactured at Lupin’s Pithampur facility in India
This product will be manufactured at Lupin’s Pithampur facility in India
This product will be manufactured at Lupin's Nagpur facility in India
In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer
NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023
The companies plan to start a pivotal Phase 3 trial in the coming months
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada
The company is confident of addressing all the observations within the stipulated time
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
Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months
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