Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s
Raichur site is the group’s largest API facility and part of a wider network of seven sites
Raichur site is the group’s largest API facility and part of a wider network of seven sites
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
Abbott's investigational Coronary Intravascular Lithotripsy (IVL) System offers a new potential treatment by using sound pressure waves to treat arterial calcium blockages
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes
The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 m
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
There are 38.4 million people with diabetes in the United States
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