Blog
RSS FeedPosted by Michael Wonder on 12 Sep 2024
Tremfya (guselkumab) receives US FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease
11 September 2024 - The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, Tremfya showed highly statistically significant ...
Posted by Michael Wonder on 12 Sep 2024
Ilya Pharma receives rare paediatric disease designation from the US FDA for emilimogene sigulactibac for the treatment of skin wounds in SAVI patients
11 September 2024 - Ilya Pharma today announced that it has received rare paediatric disease designation by the US FDA. ...
Posted by Michael Wonder on 11 Sep 2024
Neuraptive Therapeutics receives FDA breakthrough therapy designation for NTX-001
11 September 2024 - Neuraptive Therapeutics today announced that NTX-001 has been granted breakthrough therapy designation, thus providing the potential for ...
Posted by Michael Wonder on 11 Sep 2024
ARS Pharmaceuticals submits sNDA to FDA for neffy 1 mg dose for paediatric patients with type I allergic reactions who weigh 15 to 30 kg (33-66 lbs)
9 September 2024 - ARS Pharmaceuticals announced today the submission of a supplemental new drug application for neffy 1 mg ...
Posted by Michael Wonder on 10 Sep 2024
Arrowhead Pharmaceuticals receives FDA breakthrough therapy designation for plozasiran
10 September 2024 - PALISADE Phase 3 results demonstrate plozasiran reduced triglycerides by 80% from baseline and reduced the risk of ...
Posted by Michael Wonder on 10 Sep 2024
BridgeBio receives FDA’s regenerative medicine advanced therapy designation for BBP-812 Canavan disease gene therapy program
10 September 2024 - Receipt of RMAT designation is based on preliminary clinical evidence from the CANaspire Phase 1/2 clinical trial, ...
Posted by Michael Wonder on 10 Sep 2024
Cartesian Therapeutics receives FDA rare paediatric disease designation for Descartes-08 for the treatment of juvenile dermatomyositis
9 September 2024 - Cartesian Therapeutics today announced that the US FDA has granted rare paediatric disease designation to Descartes-08 ...
Posted by Michael Wonder on 09 Sep 2024
Amneal and Shilpa announce US FDA approval of Boruzu, the first ready to use version of bortezomib for subcutaneous administration
5 September 2024 - Ready to use oncology treatment used for multiple myeloma and mantle cell lymphoma. ...
Posted by Michael Wonder on 08 Sep 2024
YolTech Therapeutics receives US FDA rare paediatric disease designation for YOLT-203 in treating primary hyperoxaluria type 1
4 September 2024 - YolTech Therapeutics today announced that the US FDA has granted rare paediatric disease designation to YOLT-203 for ...
Posted by Michael Wonder on 07 Sep 2024
Axogen completes submission of biologics license application to US FDA for Avance Nerve Graft
6 September 2024 - Axogen announced that it has completed the rolling submission process for its biologics license application to the ...
Posted by Michael Wonder on 07 Sep 2024
KalVista announces FDA acceptance of new drug application for sebetralstat for oral on-demand treatment of hereditary angioedema
3 September 2024 - FDA PDUFA goal date of 17 June 2025. ...
Posted by Michael Wonder on 06 Sep 2024
Sun Pharma and Moebius Medical announce fast track designation granted for MM-II for the treatment of osteoarthritis knee pain
6 September 2024 - Sun Pharma and Moebius Medical announced that the US FDA has granted fast track designation to ...
Posted by Michael Wonder on 06 Sep 2024
Azurity Pharmaceuticals announces FDA approval of Nymalize (nimodipine) oral solution 30 mg/5 mL pre-filled ENFit syringe
3 September 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Nymalize (nimodipine) oral solution in a 30 ...
Posted by Michael Wonder on 06 Sep 2024
Travere Therapeutics announces full FDA approval of Filspari (sparsentan), the only non-immunosuppressive treatment that significantly slows kidney function decline in IgA nephropathy
5 September 2024 - Conversion to full approval based on results from the PROTECT study, where Filspari delivered superior long-term kidney ...
Posted by Michael Wonder on 05 Sep 2024
Breakthrough therapy designation for Sanbexin sublingual tablets granted by the US FDA
5 September 2024 - On 2 September 2024, Simcere Pharmaceuticals announced that Sanbexin sublingual tablets (edaravone and dexborneol sublingual tablets), an ...