A CRL and other hurdles ahead for Axsome Therapeutics’s migraine treatment, AXS-07
On April 25, Axsome Therapeutics revealed that chemistry, manufacturing and controls (CMS) issues were identified during the US Food and…
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Sinovac to initiate trial of Omicron-specific Covid-19 vaccine in China
The Omicron-specific vaccine was found to be safe and effective in animals in preclinical research.
FDA grants approval for BioCardia’s Covid-19 stem cell therapy trial
The initial portion of the trial will assess increasing doses of the NK1R+ MSCs in adult patients.
NICE’s approval of dapagliflozin allows patients to better manage their CKD
NICE’s approval of Forxiga (dapagliflozin) suggests the drug has some advantages over existing chronic kidney disease treatments.
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FDA grants clearance for Pharmazz’s Phase II trial of Covid-19 therapy
The improvement of PaO2/FiO2 ratio greater than or equal to 100mmHg will be the trial’s primary endpoint.
Potential FDA approval on the way for AbbVie’s Vraylar in major depressive disorder
GlobalData anticipates substantial uptake of Vraylar as an adjunctive treatment of major depressive disorder (MDD).
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Ardelyx’s Tenapanor receives further pushback from FDA
Tenapanor has the potential to be an alternative therapy option to traditional phosphate binders, while also offering a smaller pill…
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Roche to reassess Huntington’s asset, reviving potential for younger patients
GlobalData believes that Roche’s bid to revive tominersen is justifiable given the acute unmet needs in the Huntington’s market.
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