Blog
RSS FeedPosted by Michael Wonder on 09 Nov 2023
FDA approves first treatment for patients with rare inherited blood clotting disorder
9 November 2023 - Today, the US FDA approved Adzynma, the first recombinant protein product indicated for prophylactic or on demand ...
Posted by Michael Wonder on 09 Nov 2023
FDA amends pembrolizumab’s gastric cancer indication
9 November 2023 - On 7 November 2023, the FDA revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, ...
Posted by Michael Wonder on 09 Nov 2023
Takeda receives US FDA approval of Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer
8 November 2023 - Fruzaqla is the first targeted therapy approved for metastatic colorectal cancer regardless of biomarker status or ...
Posted by Michael Wonder on 08 Nov 2023
FDA approves new medication for chronic weight management
8 November 2023 - Today, the US FDA approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body ...
Posted by Michael Wonder on 08 Nov 2023
Zydus receives US FDA approval for Zituvimet to treat adult patients with type 2 diabetes mellitus
6 November 2023 - The company received final approval from the US FDA for its new drug application for Zituvimet ...
Posted by Michael Wonder on 02 Nov 2023
Phathom Pharmaceuticals announces FDA approval of Voquenza (vonoprazan) tablets for the treatment of erosive GERD and relief of heartburn associated with erosive GERD in adults
1 November 2023 - Voqeuenza met the primary endpoints and key secondary superiority endpoints in the pivotal Phase 3 PHALCON-EE trial ...
Posted by Michael Wonder on 01 Nov 2023
CStone announces NMPA approval of sugemalimab for patients with relapsed or refractory extranodal NK/T-cell lymphoma, the first anti-PD-1/PD-L1 mAb approved for this indication
31 October 2023 - Sugemalimab is the world’s first anti-PD-1/PD-L1 monoclonal antibody approved for relapsed or refractory extranodal NK/T-cell lymphoma indication. ...
Posted by Michael Wonder on 01 Nov 2023
FDA approves pembrolizumab with chemotherapy for biliary tract cancer
1 November 2023 - On 31 October 2023, the FDA approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin ...
Posted by Michael Wonder on 31 Oct 2023
FDA approves interchangeable biosimilar for multiple inflammatory diseases
31 October 2023 - Today, the US FDA approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) ...
Posted by Michael Wonder on 31 Oct 2023
FDA approves Novartis Cosentyx as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade
31 October 2023 - FDA approval based on robust Phase III data in which Cosentyx (secukinumab) showed rapid relief from symptoms ...
Posted by Michael Wonder on 29 Oct 2023
Coherus and Junshi Biosciences announce FDA pproval of Loqtorzi (toripalimab-tpzi) in all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma
27 October 2023 - Loqtorzi is the first and only FDA approved treatment for nasopharyngeal carcinoma. ...
Posted by Michael Wonder on 27 Oct 2023
FDA approves Genentech’s Vabysmo for the treatment of retinal vein occlusion
27 October 2023 - Approval is based on two Phase 3 studies demonstrating early and sustained vision improvements that were non-inferior ...
Posted by Michael Wonder on 27 Oct 2023
Catalyst Pharmaceuticals reports FDA approval of Agamree (vamorolone) for Duchenne muscular dystrophy granted to Santhera Pharmaceuticals
26 October 2023 - Catalyst expects to commercially launch Agamree in Q1, 2024. ...
Posted by Michael Wonder on 26 Oct 2023
FDA approves Lilly's Omvoh (mirikizumab-mrkz), a first in class treatment for adults with moderately to severely active ulcerative colitis
26 October 2023 - Omvoh achieved primary and key secondary endpoints, including sustained clinical remission in pivotal trials. ...
Posted by Michael Wonder on 24 Oct 2023
FDA approves ivosidenib for myelodysplastic syndromes
24 October 2023 - Today, the FDA approved ivosidenib (Tibsovo, Servier Pharmaceuticals) for adult patients with relapsed or refractory myelodysplastic ...