Stelis Biopharma’s facility receives EIR from USFDA
Establishment Inspection Report (EIR) from USFDA received for the drug-device combination to be commercialised from the company's…
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USFDA
USFDA pulls up Sun Pharma for lapses in Halol plant
In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces…
USFDA issues CRL for proposed biosimilar Insulin-R: Biocon
The US Food and Drug Administration (USFDA) issues a Complete Response Letter (CRL) to convey to a company that its initial review…
USFDA grants priority review to Roche’s glofitamab
If approved, glofitamab would be the first fixed-duration CD20xCD3 T-cell engaging bi-specific antibody approved to treat the most…
USFDA accepts AstraZeneca’s BLA for nirsevimab to prevent RSV lower respiratory tract disease
Nirsevimab is being developed and commercialised by AstraZeneca in collaboration with Sanofi, and is the first single-dose…
USFDA allows abortion pills to be sold at retail pharmacies
The FDA had first said it would be making those changes in December 2021 when it announced it would relax risk evaluation and…
USFDA grants appeal for Ardelyx’s kidney disease drug
The health regulator had delayed its decision on the appeal earlier this month, after calling a meeting of its advisory committee…
Alembic Pharma gets USFDA nod for Fulvestrant injection, 250 mg/5 mL per single-dose syringe
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer
USFDA issues import alert on Glenmark Pharma’s Baddi plant
As per the USFDA, import alert 66-40 implies detention without physical examination of drugs from firms which have not met drug…