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RSS FeedPosted by Michael Wonder on 01 Dec 2021
FDA approves Darzalex Faspro, Kyprolis, and dexamethasone for multiple myeloma
1 December 2021 - On 30 November 2021, the FDA approved daratumumab with hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination with ...
Posted by Michael Wonder on 01 Dec 2021
Zogenix announces U.S. FDA acceptance for priority review of supplemental new drug application for Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome
1 December 2021 - Prescription Drug User Fee Act target action date of 25 March 2022. ...
Posted by Michael Wonder on 01 Dec 2021
U.S. FDA accepts for priority review the supplemental biologics license application for Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 December 2021 - Merck today announced the U.S. FDA has accepted for priority review a supplemental biologics license application for ...
Posted by Michael Wonder on 01 Dec 2021
VBI Vaccines announces FDA approval of PreHevbrio for the prevention of Hepatitis B in adults
1 December 2021 - PreHevbrio is the only approved 3 antigen hepatitis B vaccine for adults in the U.S. ...
Posted by Michael Wonder on 01 Dec 2021
Fennec Pharmaceuticals receives complete response letter from the US FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic, solid tumours
30 November 2021 - Fennec Pharmaceuticals today announced that it received a complete response letter on 29 November 2021 from the ...
Posted by Michael Wonder on 01 Dec 2021
Secura Bio announces U.S. withdrawal of Farydak (panobinostat)
30 November 2021 - Secura Bio announced today that, based on discussions with the U.S. FDA, Secura Bio has submitted to ...
Posted by Michael Wonder on 01 Dec 2021
Silverlon receives FDA breakthrough device designation for radiation dermatitis and cutaneous radiation injury
30 November 2021 - Innovative Silverlon silver plated nylon dressing contains more metallic silver than any other dressing; anti-microbial properties of ...
Posted by Michael Wonder on 01 Dec 2021
CTI BioPharma announces extension of FDA review period for pacritinib in myelofibrosis with severe thrombocytopenia
30 November 2021 - CTI BioPharma today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 01 Dec 2021
EMA validates Atara Biotherapeutics' marketing authorisation application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
30 November 2021 - First ever off the shelf allogeneic T-cell therapy to be reviewed by any regulatory agency in the ...
Posted by Michael Wonder on 01 Dec 2021
TGA approves Nexviazyme
1 December 2021 - Avalglucosidase alfa (Nexviazyme) is a recombinant form of human acid α-glucosidase. ...
Posted by Michael Wonder on 30 Nov 2021
Hepion Pharmaceuticals receives FDA fast track designation for CRV431 for the treatment of NASH
30 November 2021 - Hepion Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for the Company’s lead ...
Posted by Michael Wonder on 30 Nov 2021
AMF Medical receives FDA breakthrough device designation for its Sigi insulin management system
30 November 2021 - Sigi is the only insulin patch pump for closed loop integration designed for use with standard, pre-filled ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for patients with certain types of endometrial carcinoma
29 November 2021 - Approval based on KEYNOTE-775/Study 309 results demonstrating statistically significant improvements in overall survival and progression-free survival ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) as first-line treatment for adult patients with advanced renal cell carcinoma
29 November 2021 - Approval Based on Results From CLEAR/KEYNOTE-581 Trial Demonstrating KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of ...
Posted by Michael Wonder on 30 Nov 2021
AbbVie submits application for risankizumab (Skyrizi) in moderate to severe Crohn's disease to European Medicines Agency
30 November 2021 - Submission supported by three pivotal Phase 3 trials in which risankizumab demonstrated significant improvements in clinical remission ...