Lupin receives US FDA approval for Brivaracetam Oral Solution 10 mg/mL
Company initiates US launch following ANDA approval for bioequivalent to Briviact
Author
Kiran Mazumdar-Shaw awarded Honorary Fellowship of the UK Academy of Medical Sciences
Biocon Group Chairperson recognised for contributions to biomedical science and access to medicines
DGFT rationalises RoDTEP scheme, reduces benefits by 50 per cent
Value caps under the scheme have also been reduced by 50 per cent wherever applicable
FDA reversal on Moderna’s mRNA-1010 can transform the seasonal influenza vaccines market: GlobalData
GlobalData highlights that the FDA’s review of Moderna’s mRNA-1010, with a 05 August 2026 PDUFA date, could introduce the first…
NIT Rourkela startup receives CDSCO approval for StopBleed Hemostat
Institute spinout Miraqules MedSolutions secures regulatory clearance for technology aimed at emergency haemorrhage control
Alembic Pharmaceuticals receives USFDA approval for Efinaconazole Topical Solution, 10%
Product is therapeutically equivalent to Jublia; company holds 234 USFDA ANDA approvals
US and Japan present narrower path for Alzheimer’s drug approvals: GlobalData
Only two monoclonal antibodies approved in both markets with no small molecules cleared
Eris Lifesciences partners Natco Pharma to commercialise Semaglutide in India
CDSCO approval enables planned March 2026 launch targeting Type 2 diabetes management
Lupin receives European Commission approval for biosimilar ranibizumab RanluspecTM
Following positive CHMP opinion, Lupin to commercialise RanluspecTM in EU through Sandoz partnership
Dr Reddy’s submits Abatacept Biosimilar BLA to USFDA for review
351(k) Biologics License Application for DRL_AB IV infusion targets rheumatoid arthritis, psoriatic arthritis and pJIA