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News about "US FDA "
US FDA Accepts sBLA for ENFLONSIA to Expand RSV Indication
US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accept applications for ENFLONSIA (clesrovimab-cfor) to expand RSV protection for high-risk children under 2 years of age during their second Respiratory Syncytial Virus (RSV) season.
US FDA | 07/08/2026 | By News Bureau
Reckitt Secures FDA Approval for First OTC Cold and Flu Innovation in 14 Years
Reckitt has received U.S. FDA approval for Mucinex 12HR Cold and Fever Multi-Symptom, marking the first over-the-counter cold and flu innovation approved in 14 years. The product combines three active ingredients in a first-of-its-kind bilayer tablet designed to deliver extended relief for multiple cold and flu symptoms.
US FDA | 06/08/2026 | By News Bureau
Genprex has partnered with Roche Diagnostics to validate TROP2 biomarkers for patient selection in non-small cell lung cancer trials, aiming to accelerate precision medicine and improve treatment outcomes.
US FDA | 04/08/2026 | By News Bureau
Cipla's InvaGen Receives US FDA EIR for New York Manufacturing Facility
Cipla's subsidiary InvaGen has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA), marking the successful closure of the inspection at its New York facility.
US FDA | 04/08/2026 | By News Bureau
US FDA Approves Lupin's Generic Diazepam Injection in Prefilled Syringe Format
Lupin has secured US FDA approval for its generic diazepam injection USP in a single-dose prefilled syringe format. The bioequivalent version of Roche's Valium injection expands the company's US injectable portfolio and addresses a market valued at nearly USD 78 million annually.
US FDA | 04/08/2026 | By News Bureau
Fresenius Wins US FDA and EMA Review Acceptance for Vedolizumab Biosimilar
Fresenius has secured US Food and Drug Administration (FDA) and European Medicines Agency (EMA) review acceptance for its vedolizumab biosimilar, targeting Ulcerative Colitis (UC) and Crohn's Disease (CD) in adults.
US FDA | 03/08/2026 | By News Bureau | 317
US FDA Expands Approval of Novartis' Pluvicto for Earlier Treatment of Advanced Prostate Cancer
The US FDA has approved Novartis' Pluvicto for use in patients with PSMA-positive metastatic hormone-sensitive prostate cancer, expanding access to the radioligand therapy at an earlier stage of disease.
US FDA | 03/08/2026 | By News Bureau
Iksuda Therapeutics Secures US FDA IND Clearance for Novel ADC Candidate IKS04 in GI Cancers
Phase 1 trial to evaluate first-of-its-kind CA242-targeted antibody-drug conjugate with an innovative co-administration regimen designed to improve solid tumour penetration and therapeutic efficacy.
US FDA | 03/08/2026 | By News Bureau
Aspen Neuroscience's Parkinson's Cell Therapy Receives US FDA RMAT Designation
Aspen Neuroscience has received US FDA Regenerative Medicine Advanced Therapy designation for sasineprocel (ANPD001), its investigational autologous cell therapy for Parkinson's disease.
US FDA | 31/07/2026 | By News Bureau
Lupin Launches Generic Sugammadex Injection in the US Following FDA Approval
Lupin launches Sugammadex Injection in the United States after receiving US FDA approval for its Abbreviated New Drug Application. The bioequivalent version of Merck's Bridion Injection is indicated for reversing neuromuscular blockade in adult and paediatric patients aged two years and older undergoing surgery.
US FDA | 31/07/2026 | By News Bureau
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