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Pharma News
Pharma News
Paradigm Health Advances FDA Real-Time Clinical Trials RFI Initiatives
Paradigm Health submits its RFI response for the FDA’s Real-Time Clinical Trials initiative, aiming to accelerate biopharma trials with AI infrastructure.
FDA Approves Ready-to-Use Aprepitant Injectable Emulsion for CINV Care
The FDA approved a ready-to-use IV Aprepitant Injectable Emulsion for preventing chemotherapy-induced nausea and vomiting (CINV) without polysorbate-80.
Medical Journal Retracts Amgen's Tavneos Drug Trial After FDA Findings
The NEJM retracted a pivotal trial article for Amgen's rare-disease drug Tavneos after an FDA investigation uncovered altered patient outcome data.
FDA Reviews Sandoz Generic GLP-1s: New Tirzepatide Weight Loss Options
The FDA is reviewing Sandoz's generic tirzepatide GLP-1s for type-2 diabetes and weight management, aiming to rival Eli Lilly's Mounjaro and Zepbound.
World-First CRISPR Gene Therapy Targets Rare CTLA-4 Immune Disorders
UK scientists develop a world-first CRISPR gene therapy to treat CTLA-4 insufficiency, a devastating rare immune disorder, with trials planned for 2028.
Ionis Grants Recordati Global Rights to Zilganersen for Alexander Disease
Ionis Pharmaceuticals partners with Recordati to commercialize zilganersen for Alexander disease globally, securing a $30M upfront licensing agreement.
Nuvectis Pharma Stock Surges 97% While Insider Buyers See 344% Gains
Nuvectis Pharma insiders reap massive rewards as stock jumps 97%. Learn what recent insider transactions suggest about the company's long-term outlook.
FDA Approves BESREMi Pen for Polycythemia Vera Self-Administration
The FDA has approved PharmaEssentia’s BESREMi Pen for adult polycythemia vera patients, offering a convenient self-administration treatment option.
FDA Issues CRL for Sobi's NASP Gout Treatment Over Manufacturing Data
Sobi receives an FDA Complete Response Letter for its NASP biologics license application for uncontrolled gout, citing manufacturing control deficiencies.
HHS & FDA Move to Fast-Track Early Drug Research and US Clinical Trials
HHS unveils a new blueprint to fast-track early drug research and streamline FDA IND applications, aiming to keep clinical trials and biotech in the US.
PRF-110 Preclinical Results Match Zynrelef for Post-Operative Pain Relief
PRF Technologies reports expanded preclinical results for PRF-110, showing comparable analgesic efficacy to Zynrelef for post-operative pain management.
MIRA Pharmaceuticals Unveils Mira-55 Preclinical Data for Chronic Pain
MIRA Pharmaceuticals reports positive preclinical data for Mira-55, a novel cannabinoid analog for chronic inflammatory pain and anxiety without THC effects.
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