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Early Access to Medicines Scheme Expands Patient Options

March 9, 2026
The Early Access to Medicines Scheme (EAMS) is designed to provide patients with life-threatening or severely debilitating conditions an opportunity to access innovative therapies that demonstrate promising efficacy compared to existing treatments. This initiative is particularly significant as it addresses the urgent need for timely therapeutic options in critical health situations. In the context of…

United Therapeutics to Seek FDA Approval for Ralinepag in Pulmonary Hypertension

March 9, 2026
United Therapeutics has announced that its investigational drug ralinepag has successfully completed a Phase 3 clinical trial, positioning the company to submit a New Drug Application (NDA) to the FDA within the year. This milestone not only reflects the drug’s efficacy in treating pulmonary arterial hypertension (PAH) but also underscores the company’s commitment to addressing…

Aardvark’s stock plummets on study pause; BioNTech heads to Phase 3 with DualityBio ADC

March 9, 2026
Aardvark Pharmaceuticals has announced a pause in its late-stage clinical trial due to concerns over reversible cardiac effects observed in participants. This decision has led to a significant decline in the company’s stock price, reflecting investor apprehension regarding the potential implications for the drug’s market viability. The pause raises questions about the robustness of Aardvark’s…

Candid, in a reverse merger with RallyBio, to go public

March 9, 2026
Candid, a biopharmaceutical company specializing in bispecific therapies for immune diseases, has announced a reverse merger with RallyBio, paving the way for its public listing. This strategic move comes alongside a significant capital raise of $505 million through private financing, which will support the newly formed entity’s ambitious development pipeline. The merger not only enhances…

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