22+ hour, 47+ min ago   (323+ words) Last week’s regulatory news saw the US Food and Drug Administration (FDA) grant accelerated approval for AstraZeneca’s Etcamah combination for the treatment of breast cancer. On the research front, Novartis suffered another setback, this time with its Phase III trial…...

3+ day, 21+ hour ago   (230+ words) The Pharma Letter - Tyra Biosciences Phase II SURF302 results support LG IR NMIBC with dabogratinib US clinical-stage biotech Tyra Biosciences (Nasdaq: TYRA) yesterday announced initial results from SURF302, its Phase II study evaluating oral dabogratinib in patients with FGFR3-altered low-grade intermediate-risk non-muscle…...

4+ day, 11+ min ago   (209+ words) The Pharma Letter - Solstice Oncology launches with $225 million to advance neoadjuvant CTLA-4 antibody USA-based Solstice Oncology has launched with a $225 million Series A financing to advance porustobart, a second-generation, Fc-enhanced CTLA-4 antibody, into neoadjuvant treatment of colon cancer. The round…...

4+ day, 20+ hour ago   (228+ words) The Pharma Letter MannKind inks obesity deal with Rose Pharma US biopharma company MannKind Corp (Nasdaq: MNKD) and Rose Pharma today announced that they have entered into a worldwide licensing and collaboration agreement to develop ROSE-010 Technosphere for weight management....

4+ day, 21+ hour ago   (230+ words) The Pharma Letter - Kura launches new company, diabetes focused Caspian Therapeutics US biotech Kura Oncology (Nasdaq: KURA) today announced the launch of Caspian Therapeutics, a separately financed company established to advance small-molecule menin inhibitors for diabetes and cardiometabolic diseases. Caspian…...

5+ day, 23+ hour ago   (228+ words) The Pharma Letter - FDA withdraws Krazati's colorectal cancer indication after confirmatory trial miss Bristol Myers Squibb (NYSE: BMY), the US pharma major, has withdrawn the accelerated approval of Krazati (adagrasib) in combination with Erbitux (cetuximab) for KRAS G12C-mutated colorectal cancer…...

6+ day, 23+ hour ago   (239+ words) The Pharma Letter - Positive results for Novo Nordisk STEP Young Phase III trial in children Danish pharma major Novo Nordisk (NOV: N) today announced first results from the STEP Young Phase III trial, evaluating once-weekly semaglutide in combination with a reduced-calorie…...

1+ week, 1+ hour ago   (263+ words) thepharmaletter.com Regulatory round-up: 7 September 2026 Medicines regulators in major international markets have issued a mix of first-in-class approvals, safety reviews, supply and shortage measures, consultations and one authorization suspension over the past week. The latest round-up includes two clearances from…...

1+ week, 5+ day ago   (212+ words) The Pharma Letter - Novartis BTK inhibitor clears Phase III hurdle in relapsing MS Swiss pharma major Novartis (NOVN: VX) has reported that its oral candidate remibrutinib significantly cut relapse rates against French drugmaker Sanofi's (Euronext: SAN) Aubagio (teriflunomide) in two Phase…...

2+ week, 3+ day ago   (216+ words) The Pharma Letter - Galen and POA Pharma launch Galsana, a new global brand for rare metabolic diseases Northern Ireland-headquartered pharma company Galen has unveiled Galsana, a new global brand uniting its metabolic disease portfolio with that of Copenhagen-based POA Pharma,…...