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RSS FeedPosted by Michael Wonder on 04 Apr 2025
Aldeyra Therapeutics receives complete response letter from the US FDA for the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease
3 April 2025 - Pending positive results and discussions with the FDA, new drug application resubmission expected mid 2025. ...
Posted by Michael Wonder on 04 Apr 2025
Helsinn submits a new formulation of Akynzeo to the EMA
2 April 2025 - Helsinn today announced the submission of a new formulation for Akynzeo to the EMA. ...
Posted by Michael Wonder on 02 Apr 2025
Denali Therapeutics announces initiation of BLA filing for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome
2 April 2025 - Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential US commercial launch in late ...
Posted by Michael Wonder on 02 Apr 2025
Apellis announces FDA acceptance and priority review of the supplemental new drug application for Empaveli (pegcetacoplan) for C3G and primary IC-MPGN
1 April 2025 - PDUFA target action date is 28 July 2025. ...
Posted by Michael Wonder on 01 Apr 2025
Vanda Pharmaceuticals announces the submission of an NDA to the FDA for Bysanti for the treatments of acute bipolar I disorder and schizophrenia
31 March 2025 - Vanda Pharmaceuticals today announced that a new drug application was submitted to the US FDA requesting marketing ...
Posted by Michael Wonder on 31 Mar 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for first-line mantle cell lymphoma
31 March 2025 - Recommendation based on ECHO Phase 3 trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 31 Mar 2025
Otsuka files biologics license application for sibeprenlimab in the treatment of immunoglobulin A nephropathy
31 March 2025 - Otsuka today announce the filing of a biologics license application with the US FDA for sibeprenlimab, ...
Posted by Michael Wonder on 30 Mar 2025
EMA validates Henlius and Organon filing for Perjeta (pertuzumab) biosimilar candidate HLX11
28 March 2025 - -Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation application for ...
Posted by Michael Wonder on 30 Mar 2025
World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men
28 March 2025 - The MHRA has approved trofolastat (RoTecPSMA), the first prostate-specific membrane antigen (PSMA)-targeting product authorised for use with ...
Posted by Michael Wonder on 30 Mar 2025
FDA issues complete response letter for etripamil for PSVT
28 March 2025 - Complete response letter focused on CMC; no clinical issues relating to etripamil raised. ...
Posted by Michael Wonder on 28 Mar 2025
Crinetics Pharmaceuticals announces EMA validation of marketing authorisation application and orphan drug designation for paltusotine in acromegaly
27 March 2025 - Crinetics Pharmaceuticals today announced that the EMA has validated the marketing authorisation application for paltusotine, the ...
Posted by Michael Wonder on 28 Mar 2025
Richter announces submission to EMA for biosimilar tocilizumab in multiple indications
27 March 2025 - Gedeon Richter announces today that the EMA has accepted Richter’s marketing authorisation application for its proposed biosimilar ...
Posted by Michael Wonder on 27 Mar 2025
Soleno Therapeutics announces US FDA approval of Vykat XR to treat hyperphagia in Prader-Willi syndrome
26 March 2025 - First approved therapy to address hyperphagia in individuals with Prader-Willi syndrome. ...
Posted by Michael Wonder on 27 Mar 2025
Savara completes submission of the biologics license application to the US FDA for Molbreevi as a treatment for auto-immune pulmonary alveolar proteinosis
26 March 2025 - Priority review was requested, commercial launch preparations ynderway. ...
Posted by Michael Wonder on 26 Mar 2025
Theratechnologies receives FDA approval for Egrifta WR (tesamorelin F8) to treat excess visceral abdominal fat in adults with HIV and lipodystrophy
25 March 2025 - New, improved formulation set to replace Egrifta SV. ...