USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

The inspection closed with zero observations

Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam

The company will submit its comprehensive response on these observations to the US FDA

Granules India receives ANDA approval for Levetiracetam Tablets

Granules now has a total of 58 ANDA approvals from US FDA

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States

Granules India received ANDA approval for Metoprolol Succinate ER Tablets

Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.

Merck gets favourable verdict in patent infringement lawsuit related to Bridion

Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.

Pfizer and GSK to battle for share of new RSV vaccine market, says GlobalData

Pfizer is likely to show GSK significant competition

Astellas submits new drug application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities

Milla receives first cycle FDA approval for Dexmedetomidine Hydrochloride Injection