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RSS FeedPosted by Michael Wonder on 27 Dec 2024
FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
27 December 2024 - Today, the FDA approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous injection across ...
Posted by Michael Wonder on 27 Dec 2024
Datroway approved in Japan as the first TROP-2 directed therapy for patients with previously treated unresectable or recurrent hormone receptor positive, HER2 negative breast cancer
27 December 2024 - First global approval based on TROPION-Breast01 where Datroway significantly reduced the risk of disease progression or ...
Posted by Michael Wonder on 26 Dec 2024
Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for patients as young as 2 years old
20 December 2024 - Rhythm Pharmaceuticals today announced that the US FDA has approved an expanded indication for Imcivree (setmelanotide) to ...
Posted by Michael Wonder on 26 Dec 2024
FDA approves first generic of once daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes
23 December 2024 - Today, the US FDA approved the first generic referencing Victoza (liraglutide injection) 18 mcg/3 mL, a ...
Posted by Michael Wonder on 23 Dec 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer
23 December 2024 - Approval based on results of the Phase 3 CheckMate-8HW trial, in which the dual immunotherapy combination ...
Posted by Michael Wonder on 23 Dec 2024
Over 1,000 people with advanced breast cancer set to benefit from new once a day tablet
19 December 2024 - We’ve issued final draft guidance recommending a new once a day tablet that is set to benefit ...
Posted by Michael Wonder on 23 Dec 2024
Tagrisso approved in the EU for patients with unresectable EGFR mutated lung cancer
23 December 2024 - Approval based on LAURA Phase 3 trial results which showed Tagrisso extended median progression-free survival to ...
Posted by Michael Wonder on 22 Dec 2024
Dong-A ST secures European approval for Stelara biosimilar Imuldosa
19 December 2024 - Global market expansion accelerates with back to back FDA and EC authorisations. ...
Posted by Michael Wonder on 22 Dec 2024
NICE recommends new treatment to prevent and reduce hearing loss in people being treated for cancer
20 December 2024 - For the first time, NICE has recommended an innovative new treatment to help stop babies, children and ...
Posted by Michael Wonder on 22 Dec 2024
Vertex announces US FDA approval of Alyftrek, a once daily next in class CFTR modulator for the treatment of cystic fibrosis
20 December 2024 - In head to head clinical trials, Alyftrek was non-inferior on ppFEV1 and further decreased sweat chloride ...
Posted by Michael Wonder on 22 Dec 2024
Vertex announces US FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include additional non-F508del Trikafta responsive variants
20 December 2024 - Approximately 300 more people with cystic fibrosis in the US are now eligible for a medicine ...
Posted by Michael Wonder on 22 Dec 2024
Givinostat conditionally approved to treat patients with Duchenne muscular dystrophy
20 December 2024 - The MHRA has today granted a conditional marketing authorisation for the medicine givinostat (Duvyzat) to treat Duchenne ...
Posted by Michael Wonder on 22 Dec 2024
FDA approves first medication for obstructive sleep apnoea
20 December 2024 - Today, the US FDA approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnoea ...
Posted by Michael Wonder on 22 Dec 2024
FDA approves first acellular tissue engineered vessel to treat vascular trauma in extremities
20 December 2024 - The US FDA approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as ...
Posted by Michael Wonder on 22 Dec 2024
FDA approves Alhemo injection as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with haemophilia A or B with inhibitors
20 December 2024 - FDA approval is based on data from the pivotal Phase 3 trial (explorer7) establishing the safety and ...