Glenmark Pharmaceutical recalls ranitidine tablets in US
The tablets are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the…
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US FDA
LifeSan Clinical Research undergoes unannounced successful inspection from US FDA
There were no 483 observations
LifeSan Clinical Research, a division of Centaur Pharmaceuticals recently underwent an…
Lupin launches generic Doxercalciferol injection in US
The injection is used for treatment of hyperparathyroidism
Lupin has launched its generic Doxercalciferol injection used for…
FDA gives green light to Tandem Diabetes Care Control-IQ Technology
Tandem Diabetes Care Control-IQ Technology is the first interoperable, automated insulin dosing controller designed to allow more…
FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy…
It is estimated that about 8 percent of patients with DMD have mutation of the dystrophin gene that is amenable to exon 53…
US FDA approves generic versions of Novartis blockbuster MS treatment
The approval allows HEC Pharm, Biocon and Sun Pharmaceutical Industries to produce the drug for the treatment of relapsing forms…
FDA approves first generics of Gilenya
Fingolimod, the drug, must be dispensed with a Medication Guide that contains important information about its uses and risks
FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns
The company was hoping to win its first approval for the therapy, RVT-802, aimed at treating congenital athymia, a disorder…
Alembic’ Aleor Dermaceuticals receives US FDA tentative approval for Diclofenac Sodium topical…
Diclofenac Sodium Topical Solution USP, 2 per cent w/w is indicated for the treatment of the pain of osteoarthritis of the knee(s)
AstraZeneca’s Imfinzi gets FDA priority review for small cell lung cancer
The company said the FDA accepted its supplemental application and granted priority review to Imfinzi for the treatment of…