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…
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Drug approvals
Biocon and Equillium expand exclusive licensing agreement for Itolizumab to include Australia and…
Equillium had originally secured exclusive rights to develop and commercialize Biocon’s novel biologic, itolizumab, for the US and…
Aurobindo Pharma gets USFDA nod for its expectorant tablets
The tablets are the generic version of RB Health (US) LLC's Mucinex tablet, the company said
Alembic Pharma gets USFDA nod for ointment to treat various skin diseases
Alembic said it has a cumulative total of 104 abbreviated new drug application (ANDA) approvals from USFDA
Lupin receives US FDA approval for Divalproex Sodium ER Tablets USP
The approval is for marketing 250 mg and 500 mg tablets
Glenmark Pharma gets USFDA nod for skin treatment ointment
The approved product is a generic version of Elidel Cream, one per cent, of Bausch Health US, LLC
Dr Reddy’s launches insomnia treatment tablets in US
The company has launched Ramelteon tablets in the strength of 8 mg after getting approval from USFDA
FDA grants approvals for generic Lyrica
The FDA granted approvals for the generic versions of Lyrica to Alembic Pharmaceuticals, Alkem Laboratories, Amneal…
Glenmark Pharma gets tentative nod from US FDA for acne treatment drug
The drug, Clindamycin Phosphate Foam, 1 per cent, is a generic version of Mylan Pharmaceuticals' Evoclin Foam