Blog
RSS FeedPosted by Michael Wonder on 13 Sep 2023
Formycon announces file acceptance for FYB203, a biosimilar candidate to Eylea (aflibercept), by the US FDA
29 August 2023 - Formycon and its license partner Klinge Biopharma announce that the US FDA has accepted the biologics license ...
Posted by Michael Wonder on 12 Sep 2023
MorphoSys receives US FDA fast track designation for tulmimetostat in endometrial cancer
12 September 2023 - Tulmimetostat follows pelabresib (2018) and tafasitamab (2014) as the company’s third clinical program to receive fast ...
Posted by Michael Wonder on 12 Sep 2023
Affimed receives FDA fast track designation for AFM13 in combination with AlloNK for the treatment of patients with relapsed or refractory Hodgkin lymphoma
12 September 2023 - Affimed today announced that the FDA has granted fast track designation to the combination of its innate ...
Posted by Michael Wonder on 11 Sep 2023
Aquestive Therapeutics receives FDA acceptance of new drug application for Libervant (diazepam) buccal film in paediatric patients and assignment of PDUFA date
11 September 2023 - PDUFA target goal date set for 28 April 2024. ...
Posted by Michael Wonder on 11 Sep 2023
BioLineRx announces FDA approval of Aphexda (motixafortide) in combination with filgrastim to mobilise haematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma
11 September 2023 - Aphexda is the first innovation in stem cell mobilisation for multiple myeloma to be approved in the ...
Posted by Michael Wonder on 11 Sep 2023
Verona Pharma announces the US FDA has accepted the new drug application filing for ensifentrine for the maintenance treatment of COPD
11 September 2023 - PDUFA target action date of 26 June 2024. ...
Posted by Michael Wonder on 10 Sep 2023
The accelerated approval program for cancer drugs — finding the right balance
9 September 2023 - Implementation of the accelerated approval program has been rocky in recent years. ...
Posted by Michael Wonder on 08 Sep 2023
Mendus receives US FDA fast track designation for vididencel in acute myeloid leukaemia
8 September 2023 - Mendus today announced that it has received fast track designation from the US FDA for the Company’s ...
Posted by Michael Wonder on 08 Sep 2023
Inovio announces US FDA breakthrough therapy designation granted for INO-3107 for the treatment of recurrent respiratory papillomatosis
7 September 2023 - Designation based on clinical evidence indicating INO-3107 may demonstrate substantial improvement over existing therapies. ...
Posted by Michael Wonder on 07 Sep 2023
Ozempic and Wegovy maker ‘just scratching the surface’ in meeting demand for weight loss drugs, CEO says
5 September 2023 - It could take years before Novo Nordisk has fulfilled demand for its highly popular weight loss ...
Posted by Michael Wonder on 06 Sep 2023
FDA accepts application for Genentech’s crovalimab for the treatment of PNH, a rare life-threatening blood condition
6 September 2023 - Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was ...
Posted by Michael Wonder on 06 Sep 2023
Update on US regulatory review of Ultomiris in NMOSD
6 September 2023 - The US FDA has issued a complete response letter regarding the supplemental biologics license application for ...
Posted by Michael Wonder on 06 Sep 2023
X4 Pharmaceuticals announces submission of new drug application to US FDA for mavorixafor in WHIM syndrome
5 September 2023 - Submission supported by positive results from global, pivotal 4WHIM Phase 3 clinical trial. ...
Posted by Michael Wonder on 05 Sep 2023
Abliva’s lead candidate KL1333 receives FDA fast track designation
4 September 2023 - Abliva today announced that the company’s lead candidate KL1333 has received fast track designation from the ...
Posted by Michael Wonder on 01 Sep 2023
Hugel resubmits BLA for its botulinum toxin, Letybo to the US FDA
1 September 2023 - Expected to obtain the US FDA's approval in the first quarter of 2024. ...