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Sarepta Therapeutics Seeks to Expand Delandistrogene Moxeparvovec Indications

Delandistrogene moxeparvovec-rokl (Elevidys; Sarepta Therapeutics) is currently approved to treat Duchenne muscular dystrophy in 4- and 5-year-old patients who have a confirmed DMD gene mutation. ....

United States , Douglass Ingram , Doug Ingram , Sarepta Therapeutics Inc Image Credit , Muscular Dystrophy Association , Sarepta Therapeutics Inc , Image Credit , Sarepta Therapeutics , Accessed January , American Journal , Managed Care , Dystrophy Association , Sarepta Therapeutic Elevidys , Innov Regul , Dystrophin Protein , Delandistrogene Moxeparvovec ,

Knight Therapeutics Announces Product Launch for IMVEXXY in Canada

Knight Therapeutics Announces Product Launch for IMVEXXY in Canada
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United States , Vivien Brown , Biotoscana Farma , Arvind Utchanah , Samira Sakhia , American Menopause Society , Clin Medinsights Reprod Health , Vaginal Health , Knight Therapeutics Inc , Intj Womens Health , Kokot Kierepam Vaginal Health , Therapeutics Inc , Health Canada Approved , Chief Executive Officer , Canadian Product Monograph , Latin American , United Medical , Looking Statements , Knight Therapeutics , Annual Report , Annual Information Form , North American Menopause , Medinsights Reprod , Innov Regul , Treatment Options , Menopausal Vaginal Changes ,

Contributor: How Patients and Caregivers Can Be a Catalyst for Rare Disease Innovation

Patient input and experiences play a crucial role in advancing rare disease research and therapy development, as they help define the disease, inform clinical trial design, and influence regulators and payers' decisions, ultimately serving as catalysts for innovation in the field. ....

United States , Kyle Bryant , Philip Cyr , Nguengang Wakap , International Meeting , Drug Administration , Friedreich Ataxia Research Alliance , Agency For Healthcare Research , Ataxia Research Alliance , Orphan Drug Act , Drug Evaluation , Innov Regul , Annual International , Annual European Meeting , Accessed September , Evaluating Patient Outcomes , Healthcare Research , Rare Disease , Future Rare , Health Access ,

Searching for Surrogates: The Effort to Speed Up Drug Trials

Identifying surrogate endpoints for use in clinical trials that strongly predict clinical outcomes such as improved survival and quality of life is challenging. ....

United States , National Institutes Of Health , San Francisco , Amaru Kishan , Hiddol Heerspink , Vincent Planche , Juliaa Beaver , Carol Taylor Burds , Los Angeles , Karin Hoelzer , Fabio Conforti , Richard Pazdur , Anushka Walia , Emersony Chen , Ginny Beakes , Fady Ghali , Rare Diseases Information Center , Pilot Meeting Program , University Of Washington School Medicine , Oncology Center , University Of California , Oregon Health Science University In Portland , International Classification Of Disease , Drug Administration , European Renal Association , University Medical Center Groningen ,

Searching for Surrogates: The Effort to Speed Up Drug Trials

Identifying surrogate endpoints for use in clinical trials that strongly predict clinical outcomes such as improved survival and quality of life is challenging. ....

United States , National Institutes Of Health , San Francisco , Fabio Conforti , Vincent Planche , Fady Ghali , Karin Hoelzer , Ginny Beakes , Carol Taylor Burds , Amaru Kishan , Richard Pazdur , Hiddol Heerspink , Anushka Walia , Los Angeles , Emersony Chen , Juliaa Beaver , University Of California , Drug Administration , Pilot Meeting Program , European Institute Of Oncology , International Classification Of Disease , European Renal Association , University Of Washington School Medicine , Oncology Center , Amgen Inc , University Medical Center Groningen ,