Press Releases
Our team at Pharmafocuseurope.com believes that press releases are an important marketing tool for highlighting a client's corporate message and ensuring it reaches their target audience. The feature can be used to publish business agreements, annual reports, financial results, corporate performances, important announcements, and any other important information that needs to be communicated to the target audience. Pharma companies can also use it to launch new products and promote existing ones.
Bayer submits EU marketing authorization application for elinzanetant to treat moderate to severe vasomotor symptoms
Tuesday, October 15, 2024Bayer has submitted a marketing authorization application MAA to the European Medicines Agency EMA for elinzanetant for the treatment of moderate to severe vasomotor symptoms VMS also known as hot flashes associated with menopause or caused by adjuva...
Majority of children with spinal muscular atrophy (SMA) treated with Roche’s Evrysdi are able to sit, stand and walk independently, two-year data demonstrate
Monday, October 14, 2024Roche presented positive twoyear data from the ongoing RAINBOWFISH study at the th World Muscle Society WMS Congress October assessing the efficacy and safety of Evrysdi risdiplam in children with SMA who were treated presymptomatically as infants...
UCB receives U.S. FDA approval for 320 mg single-injection device presentations of BIMZELX® (bimekizumab-bkzx)
Monday, October 14, 2024UCB a global biopharmaceutical company today announced that the US Food and Drug Administration FDA has approved a mL prefilled syringe and prefilled autoinjector each containing mg of BIMZELX bimekizumabbkzx
Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic non-small cell lung cancer
Monday, October 14, 2024AstraZeneca and Daiichi Sankyos Enhertu trastuzumab deruxtecan has received conditional approval in China as a monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic nonsmall cell lung cancer NSCLC whose tumo...
Ardena Signs Agreement to Expand US Footprint with the Acquisition of Advanced Drug Product Manufacturing Facility from Catalent
Monday, October 14, 2024Ardena a specialist pharmaceutical Contract Development and Manufacturing Organisation CDMO with GMP facilities in Belgium Spain the Netherlands and Sweden today announced it has signed a definitive agreement to acquire Catalents stateoftheart facili...
SkylineDx Announces Data from Largest Prospective Multi-Center Melanoma Gene Expression Profiling Trial at 21st International Congress of the Society for Melanoma Research
Sunday, October 13, 2024SkylineDx an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology inflammatory and infectious diseases announced today new data from the MERLIN prospective US multicenter trial the largest...
Alterity Therapeutics Announces Presentation of New Data Describing Neuroprotection of ATH434 at Neuroscience Meeting
Friday, October 11, 2024Alterity Therapeutics a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases today announced promising new data related to ATH were presented at the Society for Neuroscience in Chicago
FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
Friday, October 11, 2024Roche announced today that the United States Food and Drug Administration FDA approved Itovebi inavolisib in combination with palbociclib Ibrance and fulvestrant for the treatment of adults with endocrineresistant PIKCAmutated hormone receptor HRposi...
Roche obtains CE certification for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY
Thursday, October 10, 2024Roche announced today that the VENTANA CLDN A RxDx Assay is the first immunohistochemistry IHC companion diagnostic test to receive CE Mark approval for determining CLDN protein expression in tumours of patients with gastric or gastroesophageal junct...
Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism
Wednesday, October 09, 2024Zealand Pharma AS a biotechnology company focused on the discovery and development of innovative peptidebased medicines today announced that the US Food and Drug Administration FDA has issued a Complete Response Letter CRL for Part of the New Drug A...
