Blog
RSS FeedPosted 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
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 ...
Posted by Michael Wonder on 15 Mar 2024
US FDA approves Bristol Myers Squibb’s Breyanzi as the first and only CAR T cell therapy for adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
14 March 2024 - In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in ...
Posted by Michael Wonder on 14 Mar 2024
FDA approves first treatment for patients with liver scarring due to fatty liver disease
14 March 2024 - Today, the US FDA approved Rezdiffra (resmetirom) for the treatment of adults with non-cirrhotic non-alcoholic steatohepatitis with ...
Posted by Michael Wonder on 12 Mar 2024
Viatris and Mapi Pharma statement regarding new drug application for glatiramer acetate depot
11 March 2024 - Viatris has been informed that Mapi Pharma has received a complete response letter regarding the new drug ...
Posted by Michael Wonder on 08 Mar 2024
FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight
8 March 2024 - Today, the US FDA approved a new indication for use for Wegovy (semaglutide) injection to reduce the ...
Posted by Michael Wonder on 07 Mar 2024
FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma
7 March 2024 - Today, the FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) with obinutuzumab for relapsed or refractory ...
Posted by Michael Wonder on 07 Mar 2024
FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma
7 March 2024 - On 6 March 2024, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with cisplatin and gemcitabine ...
Posted by Michael Wonder on 06 Mar 2024
FDA approves inotuzumab ozogamicin for paediatric patients with acute lymphoblastic leukaemia
6 March 2024 - Today, the FDA approved inotuzumab ozogamicin (Besponsa, Pfizer) for paediatric patients 1 year and older with ...
Posted by Michael Wonder on 06 Mar 2024
Vanda Pharmaceuticals announces FDA update for supplemental NDA for Hetlioz in the treatment of insomnia
6 March 2024 - Vanda Pharmaceuticals today announced that on 4 March 2024, it received a complete response letter from ...