Pfizer announces positive topline results from Phase 3 study of Hemophilia B gene therapy candidate

MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.

Lupin receives USFDA approval for Brivaracetam Tablets

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH

USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

None of the observations are related to data integrity and management believes that they are addressable

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting

Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise

The company will submit an action plan on the observations and will engage with US FDA for next steps.

Alembic receives EIR for oncology injectable formulation facility at Panelav

This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA

Zydus receives USFDA approval to market Silodosin and Pregabalin capsules

Silodosin capsules treat signs and symptoms of an enlarged prostate gland

Roche presents new data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022

Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes