The upcoming multi-center, multinational Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy
The approval now covers procedures using 10-14F inner diameter and up to 17F outer diameter procedural sheaths
Hyderabad-based peptide specialist strengthens complex generics credentials as Apotex prepares for U.S. commercialization of semaglutide injection
The FDA clearance of Zeto New Wave marks the company’s third cleared device, alongside Zeto WR19 and Zeto ONE
The approval clears the way for a US study at leading clinical centers to evaluate the safety and effectiveness of VDYNE’s system in patients
The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market
Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
ANDA approval for 100 mg and 150 mg capsules targeting idiopathic pulmonary fibrosis opens access to a $3.76 billion market in USA
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