US FDA approves Nexviazyme for late-onset Pompe disease
The approval is based on the positive phase-III data demonstrating improvements in key disease burden measures and establishing…
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Tag
US FDA
Alkem Laboratories launches Ibuprofen, Famotidine tablets in US
The company has launched the tablets in the strength of 800 mg/26.6 mg in the United States, following an approval from the US…
Alkem Laboratories says US FDA inspection at Taloja facility ends with ‘zero’…
At the end of the inspection, no form 483 was issued, the company said
Granules Pharmaceuticals clears US FDA audit
The company had undergone the PAI audit by the US Food and Drug Administration (FDA) from 21st June, 2021 to 25th June, 2021
US FDA to review full approval of Pfizer/BioNTech’s COVID-19 vaccine by January
The target action date does not mean the approval will not happen before January, the US Food and Drug Administration's Acting…
Lupin launches Tavaborole Topical Solution in US
It is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or…
US FDA adds new warning on J&J COVID-19 vaccine for Guillain-Barre´ syndrome
It said J&J vaccine recipients should seek medical attention if they have symptoms including weakness or tingling sensations,…
Unichem Labs gets tentative US FDA approval for Sitagliptin Tablets USP
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes…
Lupin gets USFDA approval of sNDA for SOLOSEC (secnidazole) to treat trichomoniasis
SOLOSEC demonstrated a 92.2 per cent clinically and statistically significant cure rate for patients with trichomoniasis based on…
US FDA accepts Amneal’s Biologics License Application for Bevacizumab
Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA