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The US FDA has approved the SetPoint System to treat adults with mod. to sev. rheumatoid arthritis (RA) who are inadequately managed by or intolerant to existing advanced therapies,…
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The US FDA has received sNDA of Venclexta (venetoclax) & acalabrutinib in previously untreated patients with chronic lymphocytic leukemia (CLL)
sNDA was supported by AstraZeneca-sponsored P-III (AMPLIFY) trial assessing…
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IMUNON has dosed the first pts with IMNN-001 in P-III (OVATION 3) trial for the treatment of women with newly diagnosed advanced ovarian cancer
Trial will evaluate IMNN-001 (100…
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The EC has approved Attrogy (diflunisal) to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or 2 polyneuropathy in all EEA states
EC approval was based…
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PBI-Gordon Companies has reported US availability of Felycin-CA1 (sirolimus delayed-release tablets) via licensed veterinarians
Felycin-CA1 has been conditionally approved by the US FDA for managing ventricular hypertrophy in cats with…
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The US FDA has granted 510(k) clearance to CardioTag device for assessing cardiac function
Upon regulatory approval for the PCWP Analysis Software, the algorithm will be integrated with the CardioTag device…
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AbbVie has reported topline P-III (UP-AA) trial data on Rinvoq (QD) for sev. alopecia areata in adults & adolescents with a mean baseline SALT score of 83.8
Trial incl.…
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Myelodysplastic Syndrome (MDS) is a rare and aggressive blood cancer in which the bone marrow fails to produce enough healthy blood cells
As resistance to traditional treatments continues to…
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Madrigal has secured an exclusive global license from CSPC to develop, manufacture, & commercialize SYH2086 for advancing innovative combination therapies targeting MASH
As per the deal, CSPC will receive…