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RSS FeedPosted by Michael Wonder on 17 Sep 2024
BridgeBio announces infigratinib is the first ever investigational therapeutic option for achondroplasia to be awarded breakthrough therapy designation by the FDA
17 September 2024 - Breakthrough therapy designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting ...
Posted by Michael Wonder on 17 Sep 2024
FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma
17 September 2024 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of ...
Posted by Michael Wonder on 17 Sep 2024
FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer
17 September 2024 - Today, the FDA approved ribociclib (Kisqali, Novartis) with an aromatase inhibitor for the adjuvant treatment of ...
Posted by Michael Wonder on 17 Sep 2024
Poseida Therapeutics receives regenerative medicine advanced therapy designation from FDA for P-BCMA-ALLO1 to treat relapsed/refractory multiple myeloma
16 September 2024 - FDA evaluated RMAT application based on positive clinical data from ongoing Phase 1 study of P-BCMA-ALLO1. ...
Posted 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 13 Sep 2024
Johnson & Johnson seeks first EU approval of nipocalimab to treat a broad population of patients living with antibody-positive generalised myasthenia gravis
12 September 2024 - Janssen-Cilag today announced the submission of the marketing authorisation application to the EMA) seeking first approval ...
Posted by Michael Wonder on 13 Sep 2024
Dupixent (dupilumab injection) approved in Canada for the treatment of children aged 1 year and older with eosinophilic oesophagitis
12 September 2024 - This is the ninth indication for Dupixent in Canada and its second in gastroenterology. ...
Posted by Michael Wonder on 13 Sep 2024
Health Canada approves Keytruda as monotherapy for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options
12 September 2024 - Merck announced that Health Canada has granted approval of Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy ...
Posted by Michael Wonder on 12 Sep 2024
FDA authorises first over the counter hearing aid software
12 September 2024 - Today, the US FDA authorised the first over the counter hearing aid software device, Hearing Aid Feature, ...
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 ...