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Novartis gets FDA nod for second of three IgAN drugs
03 Apr 2025 18:43 GMT
… It joins the Swiss drugmaker';s complement inhibitor … (budesonide) became the first FDA-approved therapy for IgAN, … is subject to a risk evaluation and mitigation strategy (REMS) to guard against … before there were any medicines approved to treat this …
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Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN)
03 Apr 2025 04:29 GMT
… announced the US Food and Drug Administration (FDA) has granted accelerated approval … a program called the FABHALTA Risk Evaluation and Mitigation Strategy (REMS). Before patients can … care provider and pharmacist when they get a new medicine.
FABHALTA may …
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MMS Holdings' REMS─focused technology bolsters full─service risk evaluation and mitigation strategy solutions
21 Mar 2025 11:42 GMT
… (CRO) that supports the pharmaceutical and biotech industries with a … Uma Sharma at the REMS (risk evaluation and mitigation strategies) Industry Consortium Annual Meeting in … needed to effectively navigate US FDA requirements and build sustainable, …
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Trump’s new FDA commissioner might ban abortion medication
01 Apr 2025 20:43 GMT
… on the use of abortion medications.
“As FDA commissioner, Dr. Makary is … completely revoke approval of these medications,” Freya Riedlin, senior federal … the FDA’s risk evaluation and mitigation strategies, a program of ongoing monitoring of drugs deemed …
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Top 5 FDA Approvals from Q1 2025
01 Apr 2025 16:14 GMT
… US Food and Drug Administration (FDA) approved a wave … of weight loss medications, while donanemab set … (Amvuttra)
Developer: Alnylam Pharmaceuticals
Approval Date: March 20 … only through the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) program. The …
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Use of Long-Acting Injectable Antipsychotic Medications in Schizophrenia Treatment
01 Apr 2025 15:14 GMT
… drugs are still metabolized by the same enzymes and similar risk evaluation and mitigation strategies … pharmacy benefit or a medical benefit. Lower costs associated with seeking less medical … press-announcements/fda-approves-drug-new-mechanism-action- …
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Overcoming Obstacles in Prescribing High-Cost Myeloma Therapies
05 Apr 2025 02:47 GMT
… Administrative complexities, including mandatory risk evaluation and mitigation strategy (REMS) program compliance, … restricted distribution through specialty pharmacies.
2. Financial burdens … facility-administered or oral medications. However, we …
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FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
28 Mar 2025 00:10 GMT
Fresenius announced today that the FDA has approved the biologics licensing … and Osenvelt.
Although the active drug ingredient in Conexxence and and … United States, which includes a Risk Evaluation and Mitigation Strategy (REMS) program.
Bomyntra is approved …
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Collegium to Present Real-World Data at PainConnect 2025, the American Academy of Pain Medicine’s Annual Meeting
27 Mar 2025 12:00 GMT
… (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) … ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY … fda.gov/drugdisposal for additional information on disposal of unused medicines …
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Why is the most effective medication used in miscarriage care so difficult to get?
27 Mar 2025 15:46 GMT
… is regulated under the Risk Evaluation and Mitigation Strategy, a federal drug safety program used to … prescriber or by a certified pharmacy.
The only intervention Kling needed … . Supreme Court in FDA v. Alliance for Hippocratic Medicine on June 13 …