2+ day, 18+ hour ago   (417+ words) Patients with a rare autoimmune disease known as MOGAD could be just a few months away from having the first approved treatment. The FDA has just started a priority review of Roche's anti-IL-6 inhibitor Enspryng (satralizumab) for MOGAD – myelin oligodendrocyte…...

2+ day, 18+ hour ago   (562+ words) Bayer has won FDA approval for oral HER2 inhibitor Hyrnuo as a first-line treatment for advanced HER2-mutant non-small cell lung cancer (NSCLC), just a year after it was cleared as a second-line option. Hyrnuo (sevabertinib) has been cleared for earlier use…...

2+ day, 20+ hour ago   (403+ words) Pharmaceutical firms are making an expensive mistake. They develop a drug, see it through clinical trials, and only then pause to ask whether it will secure reimbursement. But by then, capital has already been committed, and the drug has already…...

3+ day, 18+ hour ago   (616+ words) The FDA has started a priority review of AstraZeneca's IL-33-targeting antibody tozorakimab for chronic obstructive pulmonary disease (COPD), setting up a decision on the would-be blockbuster in the first quarter of 2027. It's an indicator of AZ's excitement about tozorakimab that…...

4+ day, 16+ hour ago   (552+ words) Swiss biotech Pharvaris has reported positive data from a phase 3 trial of its drug for hereditary angioedema (HAE), setting up marketing applications next year. The drug – an extended-release formulation of bradykinin B2 receptor antagonist deucrictibant – achieved an 83% reduction compared to placebo…...

4+ day, 19+ hour ago   (809+ words) Drug development is an inherently risky endeavour, with the average probability of approval for a drug entering Phase I studies now sitting at just 6.7%. While much of this can be attributed to lack of efficacy, factors such as poor clinical…...

5+ day, 15+ hour ago   (159+ words) The 10th Dermatology Drug Development Summit returns in 2026 as the leading premier forum dedicated to advancing the discovery, development, and commercialization of innovative therapies for inflammatory skin disease. The meeting provides a unique opportunity to benchmark emerging science, evaluate novel targets,…...

5+ day, 17+ hour ago   (399+ words) Novo Nordisk has opted to discontinue two late-stage trials of IL-6 inhibitor ziltivekimab in heart failure, after an interim look at the data suggested they would be unlikely to show a positive result. The revelation – first reported by Endpoints – affects the…...

5+ day, 19+ hour ago   (526+ words) The FDA has gone against the advice of its own expert advisors and approved AstraZeneca's Etcamah as a frontline treatment for breast cancer. Oral selective oestrogen receptor degrader (SERD) Etcamah (camizestrant) has been cleared in the US for use in…...

1+ week, 3+ day ago   (496+ words) PMV Pharma is preparing to file for approval of its oral p53 protein reactivator drug rezatopopt in the first quarter of 2027, after reporting positive results in a phase 2 trial in ovarian cancer. That schedule means Princeton, New Jersey-based PMV has a…...