Blog
RSS FeedPosted by Michael Wonder on 19 Jan 2024
FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma
19 January 2024 - Today, the FDA approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic ...
Posted by Michael Wonder on 18 Jan 2024
US FDA declines to approve Shin Nippon Biomedical's migraine drug
17 January 2024 - The US health regulator has declined to approve Japan-based Shin Nippon Biomedical Laboratories' treatment for acute ...
Posted by Michael Wonder on 17 Jan 2024
Dupixent (dupilumab) US label updated with data further supporting use in atopic dermatitis with moderate to severe hand and foot involvement
16 January 2024 - Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult to ...
Posted by Michael Wonder on 16 Jan 2024
US FDA approves Takeda’s HyQvia as maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy
16 January 2024 - Approval based on Phase 3 ADVANCE-CIDP 1 study demonstrating a statistically significant difference in relapse rate in ...
Posted by Michael Wonder on 16 Jan 2024
Vertex announces US FDA approval of Casgevy (exagamglogene autotemcel) for the treatment of transfusion-dependent beta thalassaemia
16 January 2024 - Approximately 1,000 patients in the US 12 years of age and older are now eligible for ...
Posted by Michael Wonder on 14 Jan 2024
FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 stage III-IVA cervical cancer
15 January 2024 - On 12 January 2024, the FDA approved pembrolizumab (Keytruda) with chemoradiotherapy for patients with FIGO 2014 stage ...
Posted by Michael Wonder on 09 Jan 2024
Orphan drug label expansions: analysis of subsequent rare and common indication approvals
8 January 2024 - We found that 491 novel orphan drugs were approved between 1990 and 2022. ...
Posted by Michael Wonder on 09 Jan 2024
Astellas provides update on zolbetuximab biologics license application in US
8 January 2024 - Astellas Pharma today announced the US FDA issued a complete response letter on 4 January 2024, ...
Posted by Michael Wonder on 08 Jan 2024
US Food and Drug Administration approves Zelsumvi as a first in class medication for the treatment of molluscum contagiosum
5 January 2023 - Zelsumvi is expected to be commercially available during the second half of 2024. ...
Posted by Michael Wonder on 04 Jan 2024
2023 FDA approvals
2 January 2024 - The FDA’s Center for Drug Evaluation and Research approved 55 new drugs in 2023, as the small ...
Posted by Michael Wonder on 27 Dec 2023
Coherus announces FDA approval of Udenyca Onbody, a novel and proprietary state of the art delivery system for pegfilgrastim-cbqv
26 December 2023 - Innovative design enables five minute pegfilgrastim delivery time. ...
Posted by Michael Wonder on 27 Dec 2023
US FDA issues complete response letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility
23 December 2023 - The complete response letter is related to deficiencies identified at a third-party manufacturing facility following an inspection ...
Posted by Michael Wonder on 27 Dec 2023
Amgen provides regulatory update on the status of Lumakras (sotorasib)
26 December 2023 - FDA has issued a new post-marketing requirement. ...
Posted by Michael Wonder on 26 Dec 2023
US Food and Drug Administration issues complete response letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility
23 December 2023 - The CRL is related to deficiencies identified at a third-party manufacturing facility following an inspection but are ...
Posted by Michael Wonder on 22 Dec 2023
Wainua (eplontersen) granted first ever regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis
21 December 2023 - US FDA approval based on NEURO-TTRansform Phase 3 results showing Wainua demonstrated consistent and sustained benefit improving ...