You are here: Industry Insights > approvals

News List

Busy Month of Approvals: A Review of Oncology Drugs Approved in May in China and world market PharmaSources/Xiaobin
July 03, 2020
The first half of 2020 will pass soon. Although foreign countries are still under the shadow of the COVID-19 pandemic, China’s situation is gradually stabilizing and improving through the concerted efforts of all to fight the pandemic.
Zydus Cadila gets USFDA nod to market generic anti-diabetic drug expressbpd
March 15, 2019
The company has received tentative approval from USFDA to market Sitagliptin and Metformin Hydrochloride extended-release tablets in the strength of 50 mg/500 mg, 50 mg/1,000 mg and 100 mg/1,000 mg
Laurus Labs receives two approvals from US FDA expressbpd
March 12, 2019
Receives a final approval for Hydroxychloroquine tablets
Overview of FDA Drug Review in 2018: The Number of Novel Drugs Marketed Hit a 20-year High PharmaSources/1℃
January 03, 2019
FDA’s drug review will undoubtedly create a new record: the number of drugs approved will hit a 20-year high, being 59 by Dec. 31, 2018.
Cadila Healthcare arm gets USFDA nod for ulcer treatment injection expressbpd
December 12, 2018
Cadila Healthcare said the product will be manufactured at Liva Pharma’s manufacturing facility at Vadodara
Western Medicine Preparation Exportation of Chinese Pharmaceutical Enterprises to the U.S.(2) Xiaoyaowan
September 20, 2018
It is observed that FDA has been encouraging generic drug application in recent years, and continued to speed up review of generic drug ANDAs, with most of the approved products being competitive products of existing similar generic drugs.
Drugmakers large and small score FDA nods in busy week of approvals fiercepharma
August 27, 2018
A group of drugmakers large and small scored FDA nods in a busy week for the agency.
US regulators on track for another strong year of approvals epvantage
July 27, 2018
A nurturing regulatory environment is one of biopharma’s strongest tailwinds, and there are few signs of this petering out.