US FDA grants orphan drug status to AstraZeneca’s asthma drug Fasenra
EoE, also known as allergic oesophagitis, is an allergic inflammation of the esophagus that involves a form of white blood cell,…
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US FDA
US FDA issues three observations to Ipca Laboratories Silvassa unit
In regulatory filing to BSE, Ipca Laboratories said US FDA conducted inspection of its formulations manufacturing unit from from…
Unichem’s Laboratories gets one observation from US FDA
The company will provide response, corrective action plan within next 15 working days
Glenmark recalls Clotrimazole, Betamethasone Dipropionate cream from US market
The voluntary class III recall is due to temperature abuse
Glenmark receives ANDA approval for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL)
A generic version of Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals
US FDA pulls up Emcure Pharma for manufacturing violations at Pune plant
In the letter, the US FDA said inspectors during February 11-20 this year found significant deviations from standard manufacturing…
Roche’s personalised cancer treatment wins FDA approval
The treatment, Rozlytrek, is a tyrosine kinase inhibitor that targets patients who must be identified via genetic profiling
Building super brands
Known as the 'Sinarest company', Mumbai-based Centaur Pharma has proved that super brands can be nurtured by mid-sized pharma…
US FDA issues six observations to Natco Pharma’s API facility near Hyderabad
The company believes that none of observations are related to data integrity and that all the observations can be addressed within…
Unichem Laboratories gets US FDA nod for hypertension management
The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC