Blog
RSS FeedPosted by Michael Wonder on 07 Jan 2023
FDA grants priority review to Genentech’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma
5 January 2023 - Results from the pivotal Phase 1/2 NP30179 study showed glofitamab induced durable response rates in people with ...
Posted by Michael Wonder on 07 Jan 2023
US FDA accepts for priority review the supplemental biologics license application for Pfizer’s 20 valent pneumococcal conjugate vaccine in infants and children
6 January 2023 - If approved, the vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants ...
Posted by Michael Wonder on 06 Jan 2023
bluebird bio sells second priority review voucher for $95 million
6 January 2023 - bluebird bio today announced that it has entered into a definitive agreement to sell its second ...
Posted by Michael Wonder on 06 Jan 2023
Infex's novel AMR drug candidate MET-X receives FDA QIDP designation
5 January 2023 - Infex Therapeutics is pleased to announce that the US FDA has granted qualified infectious disease product ...
Posted by Michael Wonder on 06 Jan 2023
UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
Posted by Michael Wonder on 06 Jan 2023
AUM Biosciences receives US FDA rare paediatric disease designation for AUM302 for treatment of neuroblastoma
5 January 2023 - AUM Biosciences announced today that the US FDA has granted a rare paediatric disease designation for its ...
Posted by Michael Wonder on 27 Dec 2022
Harm Reduction Therapeutics' new drug application for RiVive over the counter naloxone nasal spray accepted and granted priority review by FDA
26 December 2022 - Low cost, over the counter naloxone nasal spray advances to FDA review. Approval would increase access ...
Posted by Michael Wonder on 18 Dec 2022
US FDA designates Alexis Bio's realSKIN as regenerative medicine advanced therapy
15 December 2022 - Alexis Bio today announced that realSKIN is the first live cell xenotransplant product to be designated ...
Posted by Michael Wonder on 07 Dec 2022
US FDA accepts for priority review the biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate for the prevention of RSV disease in older adults
7 December 2022 - If approved, RSVpreF would help address the substantial burden of RSV disease in individuals 60 years ...
Posted by Michael Wonder on 01 Dec 2022
Innoviva announces FDA acceptance and priority review of new drug application for sulbactam-durlobactam
30 November 2022 - Sulbactam-durlobactam is a targeted antibiotic that was specifically designed to treat serious infections caused by Acinetobacter baumannii, ...
Posted by Michael Wonder on 30 Nov 2022
Evkeeza (evinacumab-dgnb) sBLA for children with ultra rare inherited form of high cholesterol accepted for FDA priority review
30 November 2022 - If approved, Evkeeza would be the first and only treatment of its kind to help children ...
Posted by Michael Wonder on 30 Nov 2022
argenx enters into agreement to acquire priority review voucher
30 November 2022 - argenx today announced an agreement to acquire a US FDA priority review voucher for $102 million. ...
Posted by Michael Wonder on 29 Nov 2022
Caribou Biosciences announces the FDA granted regenerative medicine advanced therapy and fast track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy
29 November 2022 - CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. ...
Posted by Michael Wonder on 28 Nov 2022
Sarepta Therapeutics announces that US FDA has accepted for filing and granted priority review for the biologics license application for SRP-9001, Sarepta’s gene therapy for the treatment of ambulant individuals with Duchenne muscular dystrophy
28 November 2022 - Regulatory action date of 29 May 2023. ...
Posted by Michael Wonder on 23 Nov 2022
Takeda’s biologics license application for Dengue vaccine candidate (TAK-003) granted priority review by US FDA
23 November 2022 - TAK-003 is being evaluated for the prevention of Dengue disease caused by any Dengue virus serotype ...