FDA clears Cellenkos ALS drug for trial
Cellenkos, Inc., a clinical stage biotech company, has announced that the U.S. Food and Drug…
September 21, 2022 - 3 minutes
Regulatory approval
Looming challenges for Europe’s cell and gene therapy space
The double whammy of Brexit and the COVID-19 pandemic have posed major logistical challenges for…
September 20, 2022 - 7 minutes
FDA approves Heron Therapeutics’ post-op nausea and vomiting drug
Heron Therapeutics, Inc. says the U.S. Food and Drug Administration (FDA) has approved APONVIE (aprepitant)…
September 19, 2022 - 3 minutes
Treatment for adults with moderate to severe psoriasis approved by FDA
A treatment for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or…
September 12, 2022 - 3 minutes
Sensorion receives positive opinion from EMA for treatment of hearing loss
The European Medicines Agency (EMA) through its Committee for Orphan Medicinal Products (COMP) has adopted…
September 12, 2022 - 3 minutes
Integral Molecular joins FDA’s ISTAND program
Integral Molecular has been accepted into the U.S. Food & Drug Administration (FDA)'s ISTAND (Innovative…
September 8, 2022 - 2 minutes
Lytix Biopharma expanding advanced melanoma study to Europe
Lytix Biopharma, a Norwegian immuno-oncology company, has received regulatory approval from European authorities to start…
September 7, 2022 - 2 minutes
Avacta’s drug targeting soft tissue sarcoma granted Orphan Drug Designation by FDA
A drug to treat soft tissue sarcoma has been granted Orphan Drug Designation (ODD) by…
September 5, 2022 - 2 minutes
Psoriasis pustules disappear in over half of patients using Boehringer Ingelheim drug
More than half of patients treated for psoriasis with an intravenous injection showed no visible…
September 2, 2022 - 2 minutes
Sanofi’s first treatment in the U.S. approved for adults and children with ASMD
A rare, inherited disease that affects the body's ability to metabolize fat, cholesterol and lipids…
September 1, 2022 - 4 minutes
Regulatory approval given to Iceland’s EpiEndo for study of COPD treatment
A treatment for chronic respiratory disorders will be the subject of a clinical trial in…
August 31, 2022 - 2 minutes
United BioPharma gets FDA approval for phase 2 HIV drug trial
Taiwan-headquartered United BioPharma (UBP) says the U.S. Food and Drug Administration (FDA) has approved a…
August 31, 2022 - 3 minutes
