Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
31 January 2025 - Recommendation based on the Phase 2 TRANSCEND FL study in which 97.1% of patients responded to Breyanzi, ...
Posted by Michael Wonder on 31 Jan 2025
Highlights from the 27-30 January 2025 CHMP meeting
31 January 2025 - Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the ...
Posted by Michael Wonder on 31 Jan 2025
Outcomes from the December 2024 PBAC meeting
31 January 2025 - Recommendations made by the PBAC in December 2024 relating to the listing of medicines on the PBS ...
Posted by Michael Wonder on 31 Jan 2025
Rystiggo (rozanolixizumab) for generalised myasthenia gravis receives EU approval for two new administration methods
31 January 2025 - Rystiggo can now be self-administered, or administered by a caregiver, with an infusion pump or manual push ...
Posted by Michael Wonder on 31 Jan 2025
Vertex announces Casgevy reimbursement agreement for the treatment of sickle cell disease in England
31 January 2025 - Agreement means eligible sickle cell disease patients in England now have access to Casgevy. ...
Posted by Michael Wonder on 31 Jan 2025
Thousands of people with a severe dust mite allergy are set to benefit from life-changing treatment
30 January 2025 - We've recommended an innovative daily tablet treatment shown to reduce symptoms and improve quality of life. ...
Posted by Michael Wonder on 31 Jan 2025
Axsome Therapeutics announces FDA approval of Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults
30 January 2025 - A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within ...
Posted by Michael Wonder on 30 Jan 2025
Vertex announces FDA approval of Journavx (suzetrigine), a first in class treatment for adults with moderate to severe acute pain
30 January 2025 - Journavx is the first and only approved non-opioid oral pain signal inhibitor and the first new class ...
Posted by Michael Wonder on 30 Jan 2025
Drugmakers show restraint on price increases in new Trump era
28 January 2025 - Companies raised prices a median 4%, though some medicines will cost thousands of dollars more. ...
Posted by Michael Wonder on 30 Jan 2025
CMS statement on lowering the cost of prescription drugs
29 January 2025 - Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his ...
Posted by Michael Wonder on 30 Jan 2025
Ironwood Pharmaceuticals initiates apraglutide NDA submission
29 January 2025 - Initiated rolling new drug application submission, now to include long-term extension data given continued clinical improvement over ...
Posted by Michael Wonder on 30 Jan 2025
Depemokimab applications accepted for review in China and Japan for asthma with type 2 inflammation and CRSwNP
28 January 2025 - Submissions based on data from positive SWIFT and ANCHOR trials. ...
Posted by Michael Wonder on 29 Jan 2025
Santhera’s Duchenne muscular dystrophy drug Agamree accepted by SMC
16 January 2025 - The rare muscle wasting disorder affects approximately 2,500 males in the UK at any one time. ...
Posted by Michael Wonder on 29 Jan 2025
FDA grants Vicore’s buloxibutid fast track designation for idiopathic pulmonary fibrosis
29 January 2025 - Vicore Pharma today announced that the US FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 29 Jan 2025
Scholar Rock submits biologics license application to the US FDA for apitegromab as a treatment for patients with spinal muscular atrophy
29 January 2025 - Scholar Rock’s BLA submission is based on the Phase 3 SAPPHIRE trial that demonstrated a statistically significant ...