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RSS FeedPosted by Michael Wonder on 29 Aug 2023
US FDA approves Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) as first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes who may require transfusions
28 August 2023 - In a head to head study, results showed Reblozyl nearly doubled the percent of patients achieving ...
Posted by Michael Wonder on 25 Aug 2023
FDA approves Veklury (remdesivir) to treat COVID-19 in people with mild to severe hepatic impairment with no dose adjustment
24 August 2023 - This approval supports Veklury’s strong safety profile and makes Veklury the only approved COVID-19 anti-viral treatment ...
Posted by Michael Wonder on 24 Aug 2023
FDA approves first biosimilar to treat multiple sclerosis
24 August 2023 - The US FDA today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment ...
Posted by Michael Wonder on 21 Aug 2023
FDA approves first vaccine for pregnant individuals to prevent RSV in infants
21 August 2023 - Today, the US FDA approved Abrysvo (respiratory syncytial virus vaccine), the first vaccine approved for use in ...
Posted by Michael Wonder on 19 Aug 2023
Neurocrine Biosciences announces FDA approval of Ingrezza (valbenazine) capsules for the treatment of chorea associated with Huntington's disease
18 August 2023 - Neurocrine Biosciences today announced the US FDA has approved Ingrezza (valbenazine) capsules for the treatment of ...
Posted by Michael Wonder on 19 Aug 2023
Eylea HD (aflibercept) 8 mg injection approved by FDA for treatment of wet age-related macular degeneration, diabetic macular oedema and diabetic retinopathy
18 August 2023 - Approval based on the pivotal PULSAR and PHOTON trials in which Eylea HD demonstrated clinically equivalent vision ...
Posted by Michael Wonder on 19 Aug 2023
Veopoz (pozelimab-bbfg) receives FDA approval as the first treatment for children and adults with CHAPLE disease
18 August 2023 - Approval represents tenth FDA approved medicine invented by Regeneron. ...
Posted by Michael Wonder on 16 Aug 2023
US FDA approves Ipsen’s Sohonos (palovarotene) capsules, the first and only treatment for people with fibrodysplasia ossificans progressiva
16 August 2023 - Sohonos may be prescribed immediately in the US for eligible patients, aged 8 years and older ...
Posted by Michael Wonder on 15 Aug 2023
Delcath Systems announces FDA approval of Hepzato Kit for the treatment of adult patients with unresectable hepatic dominant metastatic uveal melanoma
14 August 2023 - Hepzato Kit is the only FDA approved liver directed therapy to treat metastatic uveal melanoma. ...
Posted by Michael Wonder on 14 Aug 2023
US FDA approves first therapeutic indication for Revance’s Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia
14 August 2023 - Approval expands the Daxxify label to include efficacy data over the 52 week ASPEN repeat dose clinical ...
Posted by Michael Wonder on 10 Aug 2023
FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma
10 August 2023 - On 9 August 2023, the FDA granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech) for adults with ...
Posted by Michael Wonder on 09 Aug 2023
Galera receives complete response letter from US FDA for avasopasem manganese
9 August 2023 - The Company remains committed to its goal of bringing avasopasem manganese to patients and intends to meet ...
Posted by Michael Wonder on 09 Aug 2023
FDA approves pralsetinib for non-small-cell lung cancer with RET gene fusions
9 August 2023 - Today, the FDA granted regular approval to pralsetinib (Gavreto, Genentech) for adult patients with metastatic rearranged ...
Posted by Michael Wonder on 07 Aug 2023
Qiagen receives FDA approval for companion diagnostic to Blueprint Medicines’ Ayvakit (avapritinib) in gastro-intestinal stromal tumours
7 August 2023 - QIAGEN’s therascreen PDGFRA RGQ PCR kit approved in US to aid in identifying patients with unresectable or ...
Posted by Michael Wonder on 07 Aug 2023
FDA approves Zurzuvae (zuranolone), the first and only oral treatment approved for women with postpartum depression, and issues a complete response letter for major depressive disorder
4 August 2023 - Post partum depression approval based on results from two Phase 3 clinical trials; in the SKYLARK study ...