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RSS FeedPosted by Michael Wonder on 05 Mar 2024
Formosa Pharmaceuticals and AimMax Therapeutics receive FDA approval for clobetasol propionate 0.05% ophthalmic suspension for the treatment of post-operative inflammation and pain following ocular surgery
4 March 2024 - Formosa Pharmaceuticals and AimMax Therapeutics announced today that the US FDA has approved clobetasol propionate 0.05% ...
Posted by Michael Wonder on 05 Mar 2024
Sandoz receives FDA approval for first and only denosumab biosimilars
5 March 2024 - Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference ...
Posted by Michael Wonder on 04 Mar 2024
Hugel receives US FDA approval for its botulinum toxin Letybo
3 March 2024 - Hugel becomes the first and only Korean company that have market approvals in all three major aesthetic ...
Posted by Michael Wonder on 01 Mar 2024
FDA approves amivantamab-vmjw for EGFR exon 20 insertion mutated non-small cell lung cancer indications
1 March 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for the first-line treatment of ...
Posted by Michael Wonder on 27 Feb 2024
Theratechnologies receives refusal to file letter for Trogarzo intramuscular method of administration sBLA from FDA
27 February 2024 - Theratechnologies today announced that the US FDA has issued a refusal to file letter regarding the Company’s ...
Posted by Michael Wonder on 27 Feb 2024
Minerva Neurosciences receives complete response letter from FDA for new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia
27 February 2024 - Minerva Neurosciences announced today that the US FDA has issued a complete response letter to the ...
Posted 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 ...