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Strides Pharma receives USFDA nod for two key ANDAs biospectrumasia
August 24, 2018
The USFDA also granted Strides’ request to designate the drug product under these ANDAs as a Competitive Generic Therapy (CGT)
Strides receives acceptance from USFDA for two key ANDAs expressbpd
August 23, 2018
The combined market for the two products is US$ 550 mn and it could be eligible for a potential 180-day exclusivity
Alkem Labs gets EIR from USFDA for its Daman facility expressbpd
July 25, 2018
Shares of Alkem Laboratories today closed at INR 2,026.35 per scrip on BSE
USFDA approves Mylan and Biocon’s Fulphila biospectrumasia
June 05, 2018
Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce the risk of infection following myelosuppressive chemotherapy.
USFDA approves AstraZeneca's Lokelma biospectrumasia
May 22, 2018
Lokelma is approved for the treatment of adults with hyperkalaemia
Strides Shasun receives USFDA approval for Cinacalcet Hydrochloride tablets biospectrumasia
May 03, 2018
Cinacalcet Hydrochloride tablets is a generic version of Sensipar tablets of Amgen Inc
Dr Reddy's receives EIR from USFDA for UK plant biospectrumasia
April 25, 2018
Dr Reddy's Laboratories has received an establishment inspection report (EIR) from the US health regulator after audit of its UK facility
USFDA accepts BLA for moxetumomab pasudotox by AstraZeneca biospectrumasia
April 08, 2018
The FDA has granted the moxetumomab pasudotox BLA Priority Review status with a Prescription Drug User Fee Act date set for the third quarter of 2018
USFDA approves Taiwan, China's HIV drug biospectrumasia
March 09, 2018
Trogarzo, with its unique mechanism, is the first new HIV treatment in ten years.
United States Food and Drug Administration (USFDA) - BioResearch Monitoring Program (BIMO) Conducted prnasia
November 09, 2017
Veeda CR is glad to share the successful completion of 2 USFDA Inspections at two of its locations at Ahmedabad in Sep-2017.

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