An Emergency Use Authorization (EUA) request for the use of RLF-100™ (aviptadil) in critical COVID-19 patients was submitted to the US FDA.
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Kiran Chinnalla and Julian Backhouse explain why automation for labelling in pharma can help the industry to remain compliant in the face of regulatory changes.
The FDA has given the green light to an IND and further Phase I clinical trial of Ampio Pharmaceuticals' Ampion as an inhaled COVID-19 therapy.
A Phase III trial concluded that avelumab is an effective maintenance therapy for patients with advanced or metastatic urothelial carcinoma, whose disease had not progressed after chemotherapy.
Gilead is set to acquire Immunomedics for approximately $21 billion, with the transaction anticipated to close in the fourth quarter of 2020.
A study of baricitinib in combination with remdesivir has met its primary endpoint in COVID-19 patients, by reducing time to recovery in comparison with only remdesivir.
Vaxart's application for a Phase I clinical trial to evaluate its oral COVID-19 vaccine candidate has been cleared by the FDA.
The data suggests disease deterioration was halved in the six Amyotrophic Lateral Sclerosis (ALS) patients treated with IPL344 over eight months.
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
Nine biopharma CEOs pledged to make the integrity of the scientific process and sufficient supply priorities in the development of COVID-19 vaccines.
The Investigational New Drug Application (IND) is for a Phase II trial evaluating the safety and efficacy of FSD201 (ultramicronized PEA) in hospitalised COVID-19 patients.
Nestlé Health Science will acquire Aimmune Therapeutics for a total value of $2.6 billion, extending the former's food allergy portfolio.
The FDA has expanded the Emergency Use Authorisation for Veklury (remdesivir) to treat all hospitalised patients with COVID-19.
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.