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Amphastar Secures FDA Approval for Generic Iron Sucrose Injection
The US FDA has approved Amphastar's Abbreviated New Drug Application (ANDA) for iron sucrose injection, an iron replacement product indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease.
Global Pharma | 12/08/2025 | By Dineshwori | 306
Lupin launches Glucagon for Injection USP, 1 mg/Vial in US Market
Lupin has launched its Glucagon for Injection USP, 1mg/vial emergency kit in the US, a bioequivalent to Eli Lilly’s product, for treating severe hypoglycemia and aiding certain radiologic procedures.
Global Pharma | 12/08/2025 | By Mrinmoy Dey | 142
Ono Pharmaceutical has signed a definitive agreement with Seikagaku Corporation for the co-development and exclusive marketing of Gel-One for osteoarthritis treatment in Japan.
Global Pharma | 11/08/2025 | By Mrinmoy Dey | 324
Zydus Secures Final USFDA Approval for Diltiazem Hydrochloride Tablets
Zydus Lifesciences has received final USFDA approval to market Diltiazem Hydrochloride Tablets in 30 mg, 60 mg, 90 mg, and 120 mg dosages for the treatment of chronic stable angina and angina due to coronary artery spasm in the US.
Global Pharma | 11/08/2025 | By Mrinmoy Dey | 190
Canadian biotechnology company Cardiol Therapeutics has announced topline results from its ARCHER Phase II clinical trial evaluating CardiolRx in patients with acute myocarditis.
Global Pharma | 08/08/2025 | By Dineshwori | 198
The US Food and Drug Administration (FDA) has granted accelerated approval for Jazz Pharmaceuticals' Modeyso (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with H3 K27M-mutant diffuse midline glioma – a rare and highly aggressive brain tumour – with progressive disease following prior therapy.
Global Pharma | 08/08/2025 | By Dineshwori | 464
Freenome Partners with Exact Sciences to Commercialise Blood-Based Colorectal Cancer Test
Freenome has entered into an exclusive license agreement with Exact Sciences to advance the commercialisation of its colorectal cancer (CRC) blood-based screening test.
Global Pharma | 08/08/2025 | By Dineshwori | 817
Emcure Pharma Delivers Robust Performance Across All Businesses in Q1FY26: Satish Mehta
Emcure Pharmaceuticals reported strong financial results for the first quarter of FY26, demonstrating impressive growth in both domestic and international businesses.
Global Pharma | 07/08/2025 | By Dineshwori | 479
Celltrion Secures US FDA Approval for Expanded Indication for AVTOZMA
Celltrion has received FDA approval for an expanded indication of AVTOZMA IV (tocilizumab-anoh) to treat cytokine release syndrome (CRS), achieving full indication parity with reference biologic ACTEMRA IV in the US.
Global Pharma | 07/08/2025 | By Mrinmoy Dey | 181
Sandoz Reports Strong H1 2025 Results, Accelerated Growth in Biosimilars and Generics
Sandoz has reported strong financial results for the first half of the financial year 2025, with the company’s net sales reaching USD 5.2 billion. Growth accelerated in the second quarter, driven by solid performance across both the generics and biosimilars businesses.
Global Pharma | 07/08/2025 | By Dineshwori | 695
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