Blog
RSS FeedPosted by Michael Wonder on 26 Feb 2024
Alvotech and Teva announce US approval of Simlandi (adalimumab-ryvk) injection, the first interchangeable high concentration, citrate free biosimilar to Humira
23 February 2024 - Simlandi is the first citrate free, high concentration biosimilar to be designated interchangeable to Humira in the ...
Posted by Michael Wonder on 24 Feb 2024
Venatorx and Melinta provide update on status of US new drug application for cefepime-taniborbactam
23 February 2024 - No clinical safety or efficacy issues identified. ...
Posted by Michael Wonder on 21 Feb 2024
Tecvayli (teclistamab-cqyv) biweekly dosing approved by the US FDA for the treatment of patients with relapsed or refractory multiple myeloma
20 February 2024 - Biweekly dosing with Tecvayli, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility. ...
Posted by Michael Wonder on 18 Feb 2024
FDA approves first medication to help reduce allergic reactions to multiple foods after accidental exposure
16 February 2024 - Today, the US FDA approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and ...
Posted by Michael Wonder on 16 Feb 2024
FDA approves osimertinib with chemotherapy for EGFR mutated non-small-cell lung cancer
16 February 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca) with platinum-based chemotherapy for patients with locally advanced or ...
Posted by Michael Wonder on 16 Feb 2024
FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma
16 February 2024 - Today, the FDA granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics), a tumour derived autologous T ...
Posted by Michael Wonder on 15 Feb 2024
FDA approves tepotinib for metastatic non-small-cell lung cancer
15 February 2024 - Today, the FDA granted traditional approval to tepotinib (Tepmetko, EMD Serono) for adult patients with metastatic ...
Posted by Michael Wonder on 14 Feb 2024
FDA approves first medication to treat severe frostbite
14 February 2024 - The US FDA approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk ...
Posted by Michael Wonder on 13 Feb 2024
FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
13 February 2024 - Today, the FDA approved irinotecan liposome (Onivyde, Ipsen) with oxaliplatin, fluorouracil, and leucovorin, for the first-line ...
Posted by Michael Wonder on 12 Feb 2024
FDA approves Takeda’s Eohilia (budesonide oral suspension), the first and only oral treatment in the US for eosinophilic oesophagitis
12 February 2024 - 12 weeks of treatment with Eohilia may address significant unmet needs of patients 11 years of age ...
Posted by Michael Wonder on 31 Jan 2024
Defender Pharmaceuticals receives complete response letter from the US FDA for its intranasal scopolamine new drug application for the prevention of nausea and vomiting induced by motion in adults
30 January 2024 - Defender Pharmaceuticals today announced that the US FDA has issued a complete response letter in response ...
Posted by Michael Wonder on 30 Jan 2024
Takeda’s Gammagard Liquid approved by US FDA for adults with chronic inflammatory demyelinating polyneuropathy
29 January 2024 - Approval supported by Phase 3 ADVANCE-CIDP open-label study data demonstrating safety and efficacy as an intravenous therapy ...
Posted by Michael Wonder on 26 Jan 2024
Dupixent (dupilumab) FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic oesophagitis
25 January 2024 - Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved ...
Posted by Michael Wonder on 26 Jan 2024
Theratechnologies receives complete response letter from the FDA for the F8 formulation of tesamorelin sBLA
24 January 2024 - FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicity. ...
Posted by Michael Wonder on 24 Jan 2024
Heron Therapeutics announces FDA approval of Zynrelef indication expansion to include additional orthopaedic and soft tissue procedures
23 January 2024 - Expanded indication for Zynrelef now covers approximately 13 million procedures annually. ...