News about "Food and Drug Administration "

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.

Food And Drug Administration | 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.

Food And Drug Administration | 31/07/2026 | By News Bureau

US FDA Approves Teleflex's Ezplaz Freeze Dried Plasma, First Licensed FDP in the US

Teleflex has received US FDA Biologics License Application (BLA) approval for Ezplaz Freeze Dried Plasma, the first FDA-licensed freeze-dried plasma product in the United States.

Food And Drug Administration | 31/07/2026 | By News Bureau

Lundbeck's Oral Narcolepsy Drug Candidate Receives FDA Fast Track Designation

Lundbeck has received FDA Fast Track designation for Lu AH69593, its investigational oral orexin 2 receptor agonist, accelerating the development of a potential new treatment for patients living with narcolepsy.

Food And Drug Administration | 27/07/2026 | By News Bureau

Johnson & Johnson's Ottava Robotic Surgical System Receives US FDA De Novo Authorization

Johnson & Johnson receives US FDA De Novo authorization for the Ottava Robotic Surgical System, the world's first table-integrated soft tissue robotic platform, expanding access to robotic-assisted surgery across multiple general surgery procedures.

Food And Drug Administration | 24/07/2026 | By News Bureau

FDA Grants Priority Review to Pfizer's Talzenna-Xtandi Combination Advanced Prostate Cancer

Pfizer’s Talzenna-Xtandi combination receives FDA Priority Review for HRR gene-altered metastatic castration-sensitive prostate cancer, with Phase 3 data demonstrating a 52 percent reduction in the risk of disease progression or death.

Food And Drug Administration | 24/07/2026 | By News Bureau

Dyne Therapeutics' Duchenne Muscular Dystrophy Therapy Receives FDA Priority Review

FDA accepts Biologics License Application for investigational exon 51-skipping therapy z-rostudirsen, with a regulatory decision expected by January 2027.

Food And Drug Administration | 22/07/2026 | By News Bureau

US FDA Approves Subcutaneous Sarclisa for Multiple Myeloma Across All Existing Indications

Sanofi’s SC formulation becomes the first oncology therapy approved for administration via both an on-body injector and manual subcutaneous injection, offering shorter treatment times for patients.

Food And Drug Administration | 13/07/2026 | By News Bureau

OKYO Pharma Receives FDA Support to Advance Urcosimod into Global Phase 3 Trial

Positive feedback from the US FDA has reinforced OKYO Pharma's clinical development strategy for urcosimod, with the company preparing to launch a global Phase 3 trial for neuropathic corneal pain, a debilitating eye disorder that currently lacks FDA-approved therapies.

Food And Drug Administration | 13/07/2026 | By News Bureau

US FDA Issues Complete Response Letter for Ascelia Pharma's Orviglance NDA

Ascelia Pharma has received a Complete Response Letter from the US FDA for its New Drug Application for Orviglance, prompting the company to seek further regulatory discussions while reaffirming its commitment to advancing the rare oncology therapy.

Food And Drug Administration | 06/07/2026 | By News Bureau |  274