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The FDA’s latest Untitled Letter chides Novartis for Fabhalta ad
26 Sep 2025 21:22 GMT
… its paroxysmal nocturnal hemoglobinuria treatment Fabhalta.
The letter, … at the FDA’s Office of Prescription Drug Promotion (OPDP … remained on AstraZeneca’s Soliris or Ultomiris.
As was … FDA has issued an estimated 100 warning letters to pharma and biotech …
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Spherix Global Insights Highlights Patient Influence in Shaping PNH Treatment Choices
26 Sep 2025 15:08 GMT
… physician perspectives are reshaping the treatment landscape. This update highlights both … remain a notable driver of treatment discussions. Requests most frequently centered … (AZ/Alexion), Fabhalta (Novartis), Soliris (AZ/Alexion), Empaveli (Apellis …
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These new drugs are changing lives — the NHS won’t buy them
14 Sep 2025 21:56 GMT
… .
The companies behind two other drugs, eculizumab and ravulizumab, have decided to … pay for medicines, fuelling a wider row between the pharmaceutical industry and … a decade, despite several targeted treatments for MG receiving marketing authorisation …
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AstraZeneca launches rare blood, kidney disease drug Eculizumab in India
09 Sep 2025 11:47 GMT
… Eculizumab in India
The drug is approved by the CDSCO for the treatment …
Eculizumab, a novel monoclonal antibody developed by Alexion Pharmaceuticals … to delivering innovative medicines at the earliest … 2024 annual sales, Soliris (Eculizumab) is the company’ …
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Health Technology Assessment: Evaluation of Monoclonal Antibodies for the Treatment of Neuromyelitis Optica Spectrum Disorders
08 Sep 2025 13:18 GMT
… Optica, Devic))) AND (((((((((((eculizumab) OR (Soliris)) OR (5G1.1)) … and after treatment. Randomized controlled trials (RCTs) have … treatment costs of selected medications with those of drugs … eculizumab and inebilizumab rank among the top ten pharmaceutical …
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Alzheimer’s Therapy Is Coming to the Home With FDA Approval of Injectable Eisai, Biogen Drug
02 Sep 2025 13:18 GMT
…
—FDA approval of Ionis Pharmaceuticals drug Dawnzera gives the biotech entry … authorization covers the treatment of adults with … as an adjunct to statin therapy. The latest … trial protocol specifies a lower threshold for administering the C5 inhibitor Soliris …
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Regeneron tees up myasthenia gravis drug approval after Phase III victory
27 Aug 2025 17:46 GMT
… accounting for placebo-adjusted treatment difference.
This trumps … namely Ultomiris (ravulizumab) and Soliris (eculizumab), which improved scores by - … portion of the trial, however.
The trial results mark … the siRNA from Alnylam Pharmaceuticals in June 2024. …
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Regeneron’s RNA Med for Muscle Disease Meets Trial Goals; FDA Filing Planned for Next Year
26 Aug 2025 23:06 GMT
A Regeneron Pharmaceuticals drug that lowers levels … symptom improvement and better treatment effect. Regeneron executives … an upcoming medical meeting. Pending discussions with the FDA, the … inhibitors Soliris and Ultomiris. The newest myasthenia gravis drug …
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Regeneron Eyes 2026 Filing For siRNA Myasthenia Gravis Drug After Phase III Win
27 Aug 2025 13:24 GMT
… Veopoz is approved for the treatment of patients 1 year and … point for Regeneron. The drug is given subcutaneously every 12 … notable competitors—AstraZeneca’s Soliris and Ultomiris—are delivered … Regeneron is planning an FDA submission for the first quarter …
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With late-stage trial win, Argenx preps FDA filing to push Vyvgart into broader myasthenia gravis population
25 Aug 2025 23:46 GMT
… expanded approval in the drug’s initial myasthenia gravis … the ADAPT SERON trial at an upcoming medical conference.
If Argenx … the U.S., the treatment space has become increasingly crowded … AstraZeneca’s Soliris successor Ultomiris picked up an FDA approval in …