US FDA declines to approve Y-mAbs’s paediatric cancer drug
Y-mAbs said it is assessing the implications of the Food and Drug Administration's (FDA) Complete Response Letter (CRL) and the…
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Browsing Tag
US FDA
Provention Bio diabetes drug to cost $13,850/vial
The US Food and Drug Administration (FDA) approved use of the drug, to be sold under brand name Tzield, for delaying the onset of…
Eugia Pharma receives US FDA nod for Amphotericin B Liposome Injection
Has an estimated market size of around US$ 145 million for the 12 months ending September 2022, according to IQVIA.
US FDA issues warning letter to Lupin for Maharashtra-based API plant
The FDA inspected the manufacturing facility from 22nd March to 4th April, 2022
US FDA extends review of Amicus muscle disorder therapy for second time
The agency blamed the delay on pandemic-related travel restrictions that kept it from conducting a required manufacturing site…
Three pharma companies recall products in US
The three pharma companies -- Dr Reddy's Laboratories, Cipla and Aurobindo Pharma -- are recalling different products in the US…
US FDA issues four observations to Alembic Pharma’s Panelav plant
The FDA had conducted an inspection at the facility located at Panelav from 4th to 14th October, 2022, Alembic Pharma said in a…
US health regulator extends review of Biogen’s ALS drug
Biogen said it had submitted responses to the FDA's information requests, which the agency said would require additional time for…
US FDA asks Panacea Biotec to take corrective measures at Himachal unit
The US Food and Drug Administration (FDA) had inspected the Baddi unit of its subsidiary, Panacea Biotec Pharma from 30th May to…
Aurobindo Pharma subsidiary’s plant gets one observation from US FDA
The plant is owned by Aurolife Pharma, a wholly-owned step down subsidiary of the company