Zydus receives final approval from the USFDA for Pitavastatin Tablets

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States

USFDA accepts for priority review the sNDA for Merck’s Prevymis

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients

Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg

Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)

Lupin receives EIR from USFDA for injectable facility in Nagpur

The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)

Zydus receives tentative approval from the USFDA for Canagliflozin tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya

Aurobindo Pharma gets VAI classification from USFDA for Telangana plant

Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated