NATCO launches generic Pomalidomide Capsules in Canada

Natco launched pomalidomide under their brand NAT-POMALIDOMIDE in strengths of 1 mg, 2 mg, 3 mg and 4 mg capsules

Sanofi reaffirms commitment to rare diseases in India

Receives Subject Expert Committee recommendation to bring new therapies of Pompe, ASMD to India

ENHERTU approved in China for patients with HER2 positive metastatic breast cancer treated withantiHER2-based regimens

First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.

Zydus receives final approval from the USFDA for Pitavastatin Tablets

EMA recommends refusal of the marketing authorization for Lagevrio

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.

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

Themis gets DCGI approval of Remifentanil Hydrochloride 1mg/2mg injection for import and marketing

Themis will market this drug with the brand name REMITHEM.