Blog
RSS FeedPosted by Michael Wonder on 16 Sep 2024
The sense and sensibility of sensitivity analyses
14 September 2024 - Clinicians and public health officials routinely make evidence-based decisions that affect patient and population level health. ...
Posted by Michael Wonder on 14 Sep 2024
US FDA grants RPD designation to Senhwa Biosciences silmitasertib for paediatric neuroblastoma
13 September 2024 - Senhwa Biosciences today announced that its new drug silmitasertib (CX-4945) was granted a rare paediatric disease designation ...
Posted by Michael Wonder on 13 Sep 2024
FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for adults and children 12 years and older with moderate to severe atopic dermatitis
13 September 2024 - Ebglyss provides a new first-line biologic treatment for moderate to severe atopic dermatitis that is not well ...
Posted by Michael Wonder on 13 Sep 2024
FDA approves Ocrevus Zunovo as the first and only twice a year 10 minute subcutaneous injection for people with relapsing and progressive multiple sclerosis
13 September 2024 - Ocrevus Zunovo has the potential to expand treatment options to centres without intravenous infrastructure or with intravenous ...
Posted by Michael Wonder on 13 Sep 2024
Dupixent (dupilumab) approved in the US as first and only treatment for adolescents with chronic rhinosinusitis with nasal polyps
13 September 2024 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has approved Dupixent (dupilumab) as an add-on ...
Posted by Michael Wonder on 12 Sep 2024
FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
12 September 2024 - Today, the FDA approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) for subcutaneous injection for all the ...
Posted by Michael Wonder on 12 Sep 2024
Tremfya (guselkumab) receives US FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease
11 September 2024 - The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, Tremfya showed highly statistically significant ...
Posted by Michael Wonder on 11 Sep 2024
Neuraptive Therapeutics receives FDA breakthrough therapy designation for NTX-001
11 September 2024 - Neuraptive Therapeutics today announced that NTX-001 has been granted breakthrough therapy designation, thus providing the potential for ...
Posted by Michael Wonder on 11 Sep 2024
ARS Pharmaceuticals submits sNDA to FDA for neffy 1 mg dose for paediatric patients with type I allergic reactions who weigh 15 to 30 kg (33-66 lbs)
9 September 2024 - ARS Pharmaceuticals announced today the submission of a supplemental new drug application for neffy 1 mg ...
Posted by Michael Wonder on 10 Sep 2024
Arrowhead Pharmaceuticals receives FDA breakthrough therapy designation for plozasiran
10 September 2024 - PALISADE Phase 3 results demonstrate plozasiran reduced triglycerides by 80% from baseline and reduced the risk of ...
Posted by Michael Wonder on 09 Sep 2024
Amneal and Shilpa announce US FDA approval of Boruzu, the first ready to use version of bortezomib for subcutaneous administration
5 September 2024 - Ready to use oncology treatment used for multiple myeloma and mantle cell lymphoma. ...
Posted by Michael Wonder on 07 Sep 2024
KalVista announces FDA acceptance of new drug application for sebetralstat for oral on-demand treatment of hereditary angioedema
3 September 2024 - FDA PDUFA goal date of 17 June 2025. ...
Posted by Michael Wonder on 06 Sep 2024
Sun Pharma and Moebius Medical announce fast track designation granted for MM-II for the treatment of osteoarthritis knee pain
6 September 2024 - Sun Pharma and Moebius Medical announced that the US FDA has granted fast track designation to ...
Posted by Michael Wonder on 06 Sep 2024
Azurity Pharmaceuticals announces FDA approval of Nymalize (nimodipine) oral solution 30 mg/5 mL pre-filled ENFit syringe
3 September 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Nymalize (nimodipine) oral solution in a 30 ...
Posted by Michael Wonder on 06 Sep 2024
Travere Therapeutics announces full FDA approval of Filspari (sparsentan), the only non-immunosuppressive treatment that significantly slows kidney function decline in IgA nephropathy
5 September 2024 - Conversion to full approval based on results from the PROTECT study, where Filspari delivered superior long-term kidney ...