Blog
RSS FeedPosted by Michael Wonder on 22 Oct 2024
Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly
22 October 2024 - The FDA issues a complete response letter for CAM2029 pending FDA’s assessment of responses from a third ...
Posted by Michael Wonder on 22 Oct 2024
Papillon Therapeutics receives rare paediatric disease designation from the US FDA for PPL-002 for the treatment of Danon disease
21 October 2024 - Papillon Therapeutics today announced that the US FDA has granted rare paediatric disease designation to Papillon’s PPL-002, ...
Posted by Michael Wonder on 21 Oct 2024
Protara Therapeutics granted FDA fast track designation for intravenous choline chloride for patients receiving parenteral support
21 October 2024 - Remain on track to initiate registrational THRIVE-3 trial in Q1, 2025. ...
Posted by Michael Wonder on 21 Oct 2024
Elevar Therapeutics announces FDA acceptance of new drug application resubmission for rivoceranib in combination with camrelizumab as a first-line systemic treatment for unresectable hepatocellular carcinoma
21 October 2024 - FDA sets a PDUFA target action date of 20 March 2025. ...
Posted by Michael Wonder on 21 Oct 2024
Gilead provides update on US indication for Trodelvy in metastatic urothelial cancer
18 October 2024 - Gilead Sciences today announced plans to voluntarily withdraw the US accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for ...
Posted by Michael Wonder on 20 Oct 2024
Intercept provides regulatory update regarding sNDA for Ocaliva
17 October 2024 - Intercept Pharmaceuticals today announced that the US FDA has informed the Company that it is continuing its ...
Posted by Michael Wonder on 20 Oct 2024
Avadel Pharmaceuticals announces FDA approval of Lumryz (sodium oxybate) extended release oral suspension for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy
17 October 2024 - Granted orphan drug exclusivity in paediatric narcolepsy patients 7 years and older through 16 October 2031. ...
Posted by Michael Wonder on 19 Oct 2024
FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastro-oesophageal junction adenocarcinoma
18 October 2024 - Today, the FDA approved zolbetuximab-clzb (Vyloy, Astellas Pharma), a claudin 18.2 (CLDN18.2) directed cytolytic antibody, with ...
Posted by Michael Wonder on 19 Oct 2024
Botox Cosmetic (onabotulinumtoxinA) receives FDA approval for moderate to severe vertical bands connecting the jaw and neck (platysma bands)
18 October 2024 - The only product of its kind approved for use in four aesthetic indications: temporary improvement in the ...
Posted by Michael Wonder on 18 Oct 2024
US FDA approves Vyalev (foscarbidopa and foslevodopa) for adults living with advanced Parkinson's disease
17 October 2024 - Adults treated with Vyalev reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release ...
Posted by Michael Wonder on 17 Oct 2024
The science of biosimilars - updating interchangeability
18 October 2024 - Almost 15 years ago the US FDA was given the authority to approve biosimilars through the ...
Posted by Michael Wonder on 17 Oct 2024
Tonix Pharmaceuticals announces submission of the TNX-102 SL new drug application for fibromyalgia to the US FDA
16 October 2024 - New drug application based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant ...
Posted by Michael Wonder on 17 Oct 2024
Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents
16 October 2024 - Application supported by positive results from pivotal Phase 3 EAGLE-2 and EAGLE-3 trials. ...
Posted by Michael Wonder on 17 Oct 2024
Valneva and LimmaTech awarded FDA fast track designation for tetravalent Shigella vaccine candidate S4V
16 October 2024 - Valneva and LimmaTech Biologics announced today that the US FDA has granted fast track designation to ...
Posted by Michael Wonder on 16 Oct 2024
UroGen announces FDA acceptance of its new drug application for UGN-102
15 October 2024 - PDUFA goal date set for 13 June 2025. ...