"We are excited to initiate the Phase 3 study and we believe that Piclidenoson's oral dosage and excellent safety record, ...
Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA. Piclidenoson is a novel ...
The psoriasis market is estimated at $30 Billion by 2030 and has shifted significantly to oral drugs Ramat Gan, Israel, March 24, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) ...
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Namodenoson, has been also granted Orphan Drug Designation by the FDA for pancreatic cancer. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven ...
While AI adoption in GMP settings is still evolving, regulatory agencies emphasize explainability and validation of AI models ...
Q4 2024 Earnings Call Transcript March 17, 2025 Protalix BioTherapeutics, Inc. beats earnings expectations. Reported EPS is $0.09, expectations were $0.07. Operator: Good morning, ladies and gentlemen ...
Post-authorisation safety studies (PASS) are often seen simply as a regulatory necessity, a checkbox that ensures ongoing monitoring of a treatment’s safety. However, for biotech and pharma focused on ...
Medicare is reinforcing its commitment to patient comfort in hospice care with the implementation of new Hospice Outcomes & Patient Evaluation (HOPE) requirements, effective . To support hospice ...
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