Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
As CRISPR and prime editing applications advance, researchers increasingly rely on longer guide RNAs to boost editing efficiency and reduce off-target effects
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
TB Alliance will continue to lead clinical development, while Lupin will leverage its global manufacturing, regulatory, and supply chain expertise to ensure the drug reaches patients worldwide
The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa
The Union Budget makes a clear and timely choice by placing biopharma at the centre of India’s next manufacturing wave
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