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Lupin Secures US FDA Approval for Pegfilgrastim Biosimilar Armlupeg
Lupin has received approval from the U.S. Food and Drug Administration (FDA) for its biosimilar Armlupeg (pegfilgrastim-unne), marking an important milestone in the company’s biologics journey. Armlupeg is a biosimilar to Neulasta (pegfilgrastim), a widely used therapy that helps reduce infection risk in cancer patients undergoing chemotherapy.
US FDA | 01/12/2025 | By Darshana
US FDA Grants Six More Priority Review Vouchers to Accelerate Drug Approvals
The US Food and Drug Administration (FDA) has awarded six additional companies under its “Commissioner’s National Priority Voucher” programme, bringing the total number of recipients to fifteen.
US FDA | 07/11/2025 | By Darshana | 100
WINREVAIR from Merck Gains Updated FDA Indication for Pulmonary Arterial Hypertension
Adding WINREVAIR from Merck to background PAH therapy improved exercise capacity and WHO Functional Class (FC), and reduced the risk of clinical worsening events, including hospitalisation for PAH, lung transplantation and death.
US FDA | 29/10/2025 | By Dineshwori | 104
FDA Approves Oral Semaglutide by Novo Nordisk for CV Risk Reduction in Adults with Type 2 Diabetes
Rybelsus (Semaglutide) tablets, available in 7 mg and 14 mg doses, is the only FDA-approved oral GLP-1 therapy, and is now indicated to lower the risk of Major Adverse Cardiovascular Events (MACE)—including CV death, heart attack, or stroke—in adults with type 2 diabetes at high cardiovascular risk.
US FDA | 21/10/2025 | By Dineshwori | 133
Biocon Biologics and Civica Launch Private-Label Insulin Glargine in the US
The multi-year transformational agreement between Biocon Biologics and Civica creates an exclusive distributorship arrangement where Biocon Biologics will manufacture and supply Insulin Glargine medicine to Civica, and Civica will commercialise under Biocon Biologics’ existing marketing approval.
US FDA | 21/10/2025 | By Dineshwori
MSN Laboratories Launches Affordable JAK Inhibitors to Boost Access for Indian Patients
The launch of JAK inhibitors enhances the accessibility and affordability of advanced treatments for patients suffering from various autoimmune diseases, including Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, Crohn's Disease and Atopic Dermatitis. Both molecules are also approved by the US FDA.
US FDA | 14/10/2025 | By Dineshwori | 116
CTx001, an AAV-based gene therapy, delivers a mini-CR1 protein to modulate complement pathways and address Geographic Atrophy (GA), an advanced dry AMD causing irreversible vision loss.
US FDA | 09/10/2025 | By Dineshwori | 101
Merck Completes Acquisition of Verona Pharma
The acquisition of Verona Pharma strengthens Merck’s cardio-pulmonary portfolio with addition of Ohtuvayre (ensifentrine), a first-in-class COPD maintenance treatment, that is expected to grow into the next decade.
US FDA | 08/10/2025 | By Dineshwori
Concept Life Sciences Unveils Major Expansion of UK Drug Discovery Facilities
Concept Life Sciences, a multi-disciplined contract research organisation, has officially opened its newly expanded integrated drug discovery facilities at its Chapel-en-le-Frith headquarters, establishing one of the UK’s largest drug discovery research sites.
US FDA | 30/09/2025 | By Darshana | 130
US FDA Declines Approval for Biogen's Higher-Dose Spinraza in SMA
The decision was relayed via a ‘complete response letter’ to Biogen, which clarified there were no issues with the clinical data behind the new high-dose regimen. Biogen says it will resubmit the application promptly, drawing on information that is already at hand.
US FDA | 24/09/2025 | By Darshana
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