Drug Approval | October 16, 2024
Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic
WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy
USFDA completes PAI of Lupin’s biotech facility in Pune
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
A first-in-class muscarinic agonist for the treatment of schizophrenia in adults
Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype
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