OSI Pharmaceuticals, Inc. and Genentech, Inc., announced that OSI submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the use of Tarceva (erlotinib) as a first-line maintenance therapy for people with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. Additionally, the companies announced that Roche, their international collaborator for Tarceva, filed an application in Europe with the European Medicines Agency (EMEA).

Hologic, Inc., a leading women's healthcare company dedicated to serving the healthcare needs of women, announced that the US Food and Drug Administration (FDA) has approved the company's pre-market approval (PMA) applications for both the Cervista HPV HR (high risk) and the Cervista HPV 16/18 tests.

Mylan announced Thursday it had received tentative approval for a generic version an HIV drug suitable for warmer climates.

India's Aurobindo Pharma Ltd. (524804.BY) said Thursday it has received U.S. Food and Drug Administration's tentative approval to sell generic lopinavir/ritonavir tablets.