This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC
Dr Rupali Paranjape, an experienced regulatory and compliance consultant and author of Blue Ocean of Compliance shares insights on her book in an interview with Thomas C Thottathil, Editor, www.indianpharmapost.com
Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine
The Portal BioRRAP will cater to all those seeking regulatory approval for biological research
Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date
Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in pediatric enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) patients in the EU
PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection
With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction
Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020
The vaccine was found to have 64% efficacy against symptomatic disease and 92% against severe Covid-19
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