Wockhardt Limited, a leading pharmaceutical and biotechnology company, released its second-quarter financial results for the fiscal year 2024-25, showing significant growth across several critical areas. Revenue for Q2 rose by 7% year-on-year to ₹818 crore, up from ₹762 crore in the previous year, while EBITDA surged by an impressive 71%, reaching ₹139 crore compared to […]
FELIQS, a multinational clinical-stage biopharmaceutical firm headquartered in Japan, has announced that its leading asset, FLQ-101, has received Fast Track designation from the U.S. Food and Drug Administration (FDA). This groundbreaking small molecule is designed to prevent retinopathy of prematurity (ROP), a severe eye disorder impacting premature neonates. FELIQS is set to initiate its Phase […]
Orthocell, an Australian regenerative medicine company, has achieved a significant milestone with the receipt of major international regulatory approval for its nerve repair product Remplir from Singapore’s Health Sciences Authority (HSA). This regulatory clearance authorizes Orthocell to initiate sales in Singapore, marking the first international regulatory authorization for Remplir outside of Australia and New Zealand, […]
Wockhardt Limited announced that its investigational drug Zaynich (Zidebactam/Cefepime) has successfully treated a complex case of bacterial meningitis caused by a pan-drug-resistant superbug under compassionate use. This breakthrough marks another instance where the novel antibiotic has proven its efficacy against critical infections, particularly those caused by multi-drug-resistant bacteria. The patient, a 64-year-old man with Type […]
Galderma has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approving Nemluvio (nemolizumab) for the treatment of prurigo nodularis in adults. This approval allows Nemluvio to be administered as a pre-filled pen for subcutaneous injection, providing a new option for patients suffering from this challenging condition. The drug’s approval follows its […]
Lupin Limited has reported a remarkable financial performance for the quarter ending June 30, 2024. The pharmaceutical giant’s sales for Q1 FY2025 reached INR 55,143 million, marking a 12.7% increase from Q4 FY2024 and a 16.3% rise from Q1 FY2024. The company’s EBITDA surged by 27.5% quarter-on-quarter to INR 13,088 million, a 48.9% year-on-year increase. […]
Lupin Limited (Lupin), a global pharmaceutical powerhouse, has been awarded the Establishment Inspection Report (EIR) by the United States Food and Drug Administration (U.S. FDA). The EIR pertains to Lupin’s manufacturing facility located in Dabhasa, Gujarat, following an inspection that took place from April 8 to April 12, 2024. This rigorous inspection concluded without any […]