Category Regulatory

Roche’s Ocrevus Recommended for EU Approval in Children and Adolescents With Relapsing Multiple Sclerosis

Roche’s Ocrevus Gains Positive CHMP Opinion for Pediatric Multiple Sclerosis in Europe Roche (SIX: RO, ROP; OTCQX: RHHBY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the…

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LEO Pharma Gains FDA Priority Review for Dersimelagon NDA and Completes Tanabe Pharma Acquisition

LEO Pharma Gains FDA Priority Review for Dersimelagon NDA Following Acquisition of Global Rights LEO Pharma, a global leader in medical dermatology, has announced two significant developments for dersimelagon, an investigational oral therapy being developed for the rare genetic skin…

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Faeth Therapeutics Appoints Karen Vousden, Ph.D., to Board of Directors

Faeth Therapeutics Appoints Cancer Biology Expert Karen Vousden, Ph.D., to Board of Directors Faeth Therapeutics, Inc. (Nasdaq: FTH), a clinical-stage biotechnology company developing therapies designed to improve outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways, has announced…

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Scholar Rock Announces FDA Approval of ISEMBYLD™ for Spinal Muscular Atrophy

Scholar Rock Wins FDA Approval for ISEMBYLD, First Muscle-Targeted Treatment for Spinal Muscular Atrophy Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company focused on developing therapies for rare, severe and debilitating neuromuscular diseases through its expertise in myostatin biology, announced…

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Mirum Pharmaceuticals Appoints Dr. Rob Myers as Chief Medical Officer

Mirum Pharmaceuticals Appoints Rob Myers, M.D. as Chief Medical Officer to Lead Global Medical and Clinical Development Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a rare disease-focused pharmaceutical company developing medicines for patients with serious and often underserved conditions, has announced the…

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Prilenia Appoints Frederick (Rick) Munschauer, MD, FAAN, as Chief Medical Officer

Prilenia Therapeutics Appoints Neurology Expert Rick Munschauer as Chief Medical Officer Prilenia Therapeutics B.V., a biopharmaceutical company focused on developing potential treatments for neurodegenerative diseases, has announced the appointment of Frederick (Rick) E. Munschauer III, MD, MSc, FAAN, as its…

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