Promius Pharma receives FDA approval for Sernivo spray
Sernivo spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older
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US Food and Drug Administration
Biosimilar trends in 2016
Spurring the growth of biosimilars is the need to improve access to biologics and contain treatment costs and healthcare budgets,…
US FDA warns of serious data integrity violations at DRL
The US Food and Drug Administration has warned DRL over serious data integrity violations, placing all its new applications or…
Regulatory submission for Sandoz’ proposed biosimilar pegfilgrastim accepted by FDA
Proposed biosimilar pegfilgrastim filing is the second of ten regulatory filings planned over the next three years
Sandoz, a…
US FDA approves ipilimumab
Ipilimumab improved adjuvant treatment of patients with cutaneous melanoma
The US Food and Drug Administration (FDA) has approved…
Sandoz launches Zarxio, the first biosimilar in US
Sandoz One Source, a patient services centre, was also launched
Zarxio by Sandoz, a Novartis company, is now available in the US.…
Sun Pharma, Wockhardt recall drugs from US market
Sun Pharma’s recall was initiated last month under Class-III classification while Wockhardt's recall was under class-II…
US FDA approves Repatha to treat certain patients with high cholesterol
The most common side effects of Repatha include nasopharyngitis, upper respiratory tract infection, flu, back pain, and reactions…
Aurobindo gets US FDA nod for hepatitis B drug
Entecavir tablets are indicated for treatment of chronic hepatitis B virus infection of the liver
Aurobindo Pharma has received…
US FDA approves Sun Pharma’s Ximino capsules
Ximino extended-release capsules are indicated for inflammatory lesions of non-nodular moderate to severe acne vulgaris in…