Blog
RSS FeedPosted by Michael Wonder on 22 Mar 2024
Outlook Therapeutics receives European Union positive CHMP opinion for ONS-5010 as a treatment for wet AMD
22 March 2024 - Positive opinion serves as a basis for final decision for potential authorisation from the European Commission ...
Posted by Michael Wonder on 22 Mar 2024
Novartis Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria
22 March 2024 - Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior haemoglobin improvement in the ...
Posted by Michael Wonder on 22 Mar 2024
Awiqli (once-weekly basal insulin icodec) recommended for approval for the treatment of diabetes by the European regulatory authorities
21 March 2024 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 22 Mar 2024
UCB receives positive CHMP opinion for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa
22 March 2024 - Positive CHMP opinion is supported by data from the two Phase 3 studies, BE HEARD I ...
Posted by Michael Wonder on 21 Mar 2024
FDA approves non-steroidal treatment for Duchenne muscular dystrophy
21 March 2024 - Today, the US FDA approved Duvyzat (givinostat) oral medication for the treatment of Duchenne muscular dystrophy in ...
Posted by Michael Wonder on 21 Mar 2024
Ferinject approved by Health Canada for the treatment of iron deficiency anaemia in adult and paediatric patients and iron deficiency in adult patients with heart failure
19 March 2024 - CSL Vifor today announced that Health Canada has authorised Ferinject (ferric carboxymaltose) for the intravenous treatment of ...
Posted by Michael Wonder on 20 Mar 2024
Phanes Therapeutics' PT886 granted fast track designation for the treatment of patients with metastatic claudin 18.2 positive pancreatic adenocarcinoma by the FDA
20 March 2024 - Phanes Therapeutics announced today that the US FDA has granted fast track designation to PT886 for the ...
Posted by Michael Wonder on 20 Mar 2024
Spevigo approved for expanded indications in China and the US
19 March 2024 - The US FDA’s approval expands the use of Spevigo to include the treatment of generalised pustular psoriasis in ...
Posted by Michael Wonder on 20 Mar 2024
A lifesaving therapy for children with a rare disease is now the world’s most expensive drug, raising questions about access
20 March 2024 - A new gene therapy for the fatal genetic disorder metachromatic leukodystrophy, or MLD, will carry a ...
Posted by Michael Wonder on 20 Mar 2024
Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) becomes first CAR T cell therapy approved in the European Union in earlier lines for triple-class exposed relapsed and refractory multiple myeloma
20 March 2024 - Abecma demonstrated superiority over standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in ...
Posted by Michael Wonder on 20 Mar 2024
US FDA approves Idorsia’s once-daily Tryvio (aprocitentan) – the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives
20 March 2024 - Idorsia plans to make Tryvio available to the millions of patients in the US who are not ...
Posted by Michael Wonder on 19 Mar 2024
FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia
19 March 2024 - Today, the FDA granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals) with chemotherapy for adult patients ...
Posted by Michael Wonder on 18 Mar 2024
FDA approves first gene therapy for children with metachromatic leukodystrophy
18 March 2024 - Today, the US FDA approved Lenmeldy (atidarsagene autotemcel), the first FDA approved gene therapy indicated for the ...
Posted by Michael Wonder on 18 Mar 2024
Xhance approved by FDA as first and only medication indicated for treatment of adults with chronic rhinosinusitis without nasal polyps
15 March 2024 - ReOpen was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms ...
Posted by Michael Wonder on 17 Mar 2024
BeiGene receives FDA approval for Tevimbra for the treatment of advanced or metastatic oesophageal squamous cell carcinoma after prior chemotherapy
14 March 2024 - Results from the global, Phase 3 RATIONALE 302 trial showed Tevimbra prolonged the survival of patients who ...