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Scynexis recalls Brexafemme tablets over potential cross contamination risk
Scynexis has recalled the drug over potential risk of cross contamination with a non-antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the tablets
FDA approves Fabre-Kramer’s Exxua for major depressive disorder
The drug’s mechanism of targeted single serotonin (5HT) 1a receptor agonism reduced depressive symptoms with an acceptable side effect profile in a trial involving more than 5,000 patients
Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept to Treat Adults with PAH
If approved, sotatercept would be the first in its class, bringing a novel approach to address a rare and progressive disease of the pulmonary arteries
Sun Nuclear SunSCAN™ 3D Water Scanning System Receives CE Marking
Faster, Hyper-Accurate Commissioning and Beam Scanning Solution Now Available in Countries Requiring CE Marking
British Heart Foundation Features Breakthrough Heart Attack Prevention Technology in Online News Programme for World Heart Day
CaRi-Heart® Users share Excitement on Potential for Heart Attack Prediction and Prevention
Viatris, Ocuphire get FDA approval for Ryzumvi eye drops to treat mydriasis
The FDA approval was supported by the data from the MIRA trial programme in which the percentage of subjects with study eyes returning to 0.2 mm from baseline pupil diameter was statistically significantly higher in the Ryzumvi group
US FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis
ENTYVIO Is the Only FDA-Approved Ulcerative Colitis Biologic That Offers the Choice of Intravenous or Subcutaneous Maintenance Therapy
Biogen Completes Acquisition of Reata Pharmaceuticals
Reata acquisition bolsters Biogen’s rare disease portfolio with the addition of SKYCLARYS (omaveloxolone), the first and only FDA approved treatment for Friedreich’s ataxia in the US
Eisai, Biogen’s Leqembi Intravenous Infusion cleared for AD treatment in Japan
The Japanese approval was based on Phase 3 results from Eisai’s large, global Clarity AD clinical trial in which the antibody therapy met its primary endpoint and all key secondary endpoints
AbbVie secures EC’s approval for Tepkinly to treat relapsed or refractory DLBCL
The conditional approval is based on the results from the EPCORE NHL-1 Phase 1/2 trial in which the DLBCL patients treated with Tepkinly achieved an overall response rate of 62% and a complete response rate of 39%