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RSS FeedPosted by Michael Wonder on 25 Jun 2024
Oncoinvent receives FDA fast track designation for Radspherin as treatment for peritoneal carcinomatosis from ovarian cancer
24 June 2024 - Phase 2b trial of Radspherin to treat ovarian cancer patients expected to initiate imminently. ...
Posted by Michael Wonder on 25 Jun 2024
BioNTech and DualityBio receive FDA fast track designation for antibody-drug conjugate candidate BNT324/DB-1311 in prostate cancer
24 June 2024 - Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with ...
Posted by Michael Wonder on 25 Jun 2024
Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute lymphoblastic leukaemia
24 June 2024 - Sellas Life Sciences today announced that the US FDA has granted rare paediatric disease designation to SLS009, ...
Posted by Michael Wonder on 24 Jun 2024
argenx announces FDA approval of Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy
21 June 2024 - Third approved indication for Vyvgart and Vyvgart Hytrulo franchise. ...
Posted by Michael Wonder on 23 Jun 2024
Lexicon Pharmaceuticals resubmits sotagliflozin NDA for type 1 diabetes
21 June 2024 - Lexicon seeks approval for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with ...
Posted by Michael Wonder on 23 Jun 2024
The opaque industry secretly inflating prices for prescription drugs
21 June 2024 - Pharmacy benefit managers are driving up drug costs for millions of people, employers and Government. ...
Posted by Michael Wonder on 23 Jun 2024
Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy
20 June 2024 - For a third time, Sarepta Therapeutics has convinced a top FDA official to overrule the prevailing ...
Posted by Michael Wonder on 23 Jun 2024
Neurotech Pharmaceuticals receives priority review of biologics license application for NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia type 2
20 June 2024 - Priority review granted with a PDUFA goal date set for 17 December 2024. ...
Posted by Michael Wonder on 21 Jun 2024
FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C mutated colorectal cancer
21 June 2024 - Today, the FDA granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics) plus cetuximab for adults with ...
Posted by Michael Wonder on 21 Jun 2024
Johnson & Johnson submits application to US FDA seeking approval of Tremfya (guselkumab) for the treatment of moderately to severely active Crohn's disease
20 June 2024 - Submission is supported by 48 week results from the Phase 3 GALAXI and GRAVITI programs. ...
Posted by Michael Wonder on 20 Jun 2024
FDA expands approval of gene therapy for patients with Duchenne muscular systrophy
20 June 2024 - Today, the FDA expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment ...
Posted by Michael Wonder on 20 Jun 2024
FDA approval of Sofdra - the first new drug for primary axillary hyperhidrosis
20 June 2024 - FDA approval was supported by results from the two pivotal Phase 3 studies evaluating the efficacy ...
Posted by Michael Wonder on 20 Jun 2024
What good are whizzy new drugs if the world can’t afford them?
14 June 2024 - Bringing gene therapies and obesity drugs to the masses will require financial innovation too, says Steven Pearson. ...
Posted by Michael Wonder on 20 Jun 2024
Aurion Biotech receives breakthrough therapy designation and regenerative medicine advanced therapy designation for its drug candidate AURN001
19 June 2024 - First allogeneic cell therapy to receive both FDA designations for the treatment of corneal oedema secondary to ...
Posted by Michael Wonder on 19 Jun 2024
How AI is revolutionising drug development
17 June 2024 - In high-tech labs, workers are generating data to train AI algorithms to design better medicine, faster. But ...