A constitutional challenge to the Biden administration program enabling Medicare to negotiate lower prices for prescription ...

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday told the U.S. District Court for the District of ...

Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug ...

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ...

Zydus' agreement with Viwit Pharmaceuticals covers the supply of gadobutrol and gadoterate meglumine injections, widely used ...

Amphastar Pharmaceuticals has seen significant growth since its IPO, with its stock price increasing over 500%. Learn more ...

Indies Pharma applied to the FDA in January 2023, for which a decision was expected in November, but received approval on ...

The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” ...

Aurobindo Pharma's stepdown subsidiary, Eugia Steriles Private Ltd, has received its first product approval from the US FDA ...

Aurobindo Pharma Ltd. announced on Wednesday that a new injectable facility of Eugia Steriles Private Ltd., which was ...

The FDA approved Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL), Aurobindo Pharma said ...

Aurobindo Pharma Ltd announced that its subsidiary, Eugia Steriles Private Limited, received its first product approval from ...