Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets

Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA

Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP

he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).

Lupin and I'rom signs licensing agreement for Denosumab biosimilar for Japan

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union

Sanofi updates on amcenestrant clinical development program

The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial

Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU

DCGI approves Enzene biosimilar Denosumab for Osteoporosis

This is Enzene Biosciences third biosimilar to be approved

Zydus Cadila receives approval from USFDA for Fulvestrant Injection

The group now has 320 approvals and has so far filed over 400 ANDAs