The various facets of drug dissolution
Drug dissolution, a key attribute for determining the bioavailability of a drug, first became official in the United States…
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Browsing Tag
US FDA
Lupin sells stakes in Kyowa but its not a Sayonara
With headwinds in overseas markets, it is vital for pharma companies in India to grow their presence in the domestic market. But…
FDA approves new treatment for adults with partial-onset seizures
The safety and efficacy of XCOPRI to treat partial-onset seizures was established in two randomized, double-blind,…
FDA approves first treatment for inherited rare disease
The approval of the drug, Givlaari was based on the results of a clinical trial of 94 patients with acute hepatic porphyria
Quality by Design (QbD) and its implementation in Pharma Industry
Ranjit Barshikar, QbD/cGMP consultant; Quality Expert - Consulting at United Nations MPP projects and member of Editorial Board of…
Novartis gets US nod for long-delayed Amgen copycat
Novartis's biosimilar, called Ziextenzo, is aimed at helping cancer patients boost infection-fighting white blood cells during…
Lupin receives sANDA approval from US FDA for Levothyroxine Sodium Tablets USP
To market a generic equivalent of LEVOXYL which is indicated for the treatment of hypothyroidism and used for pituitary…
Cadila Healthcare gets EIR from US FDA for Baddi facility
The United States Food and Drug Administration (US FDA) had conducted an inspection at the facility from July 15 to 19, 2019,"…
FDA approves Biogen and Alkermes’ multiple sclerosis drug
The approval is good news for Biogen as its top-selling drug Tecfidera, also a multiple sclerosis treatment, is facing patent…
Novartis’ Zolgensma study halted by FDA amid safety questions
The US Food and Drug Administration's partial hold on the so-called STRONG trial impacts patients aged up to five with spinal…