Orbicular, Apotex win tentative USFDA nod for generic Ozempic

Hyderabad-based peptide specialist strengthens complex generics credentials as Apotex prepares for U.S. commercialization of semaglutide injection

VDYNE gets FDA nod to launch pivotal US trial for tricuspid valve device

The approval clears the way for a US study at leading clinical centers to evaluate the safety and effectiveness of VDYNE’s system in patients

Lupin scores major US breakthrough with FDA nod for key diabetes drug

The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets

India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters

In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga

GSK Pharma shareholders back Ronojit Biswas’ Board, CFO appointment via postal ballot

Both ordinary resolutions sail through with over 99.6% votes in favour, strengthening leadership continuity at the drugmaker

Dr. Jitendra Singh urges industry to step up R&D collaboration

Minister highlights RDI fund, private participation in space and nuclear sectors, and calls for faster reforms to improve ease of research in India

Gilead to acquire Tubulis for up to $5 billion to strengthen its oncology portfolio

The acquisition complements Gilead’s existing oncology expertise and development infrastructure

RoosterBio taps MineBio to supercharge hMSC & exosome solutions in China

Johnson & Johnson unveils Varipulse Pro in Europe for faster & safer heart procedures

The new device promises faster, more efficient cardiac procedures while maintaining the safety and effectiveness clinicians expect

Lupin wins USFDA nod for generic Dapagliflozin tablets

Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market