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The application, based on the Phase III SAFFRON trial, targets patients who progressed on EGFR-TKI therapy with MET overexpression or amplification.
SEC filing (2)
Daly, former Catalyst Pharmaceuticals CEO, joins effective October 14, 2026, as the company prepares for a potential launch of its allergy drug Anaphylm.
SEC filing
The triple-combination inhaler becomes the first of its kind cleared in the EU for asthma patients 12 and older regardless of exacerbation history.
SEC filing
Both positive opinions came on September 21, 2026, based on Phase III trial data in generalised myasthenia gravis and HER2-positive early breast cancer.
SEC filing (2)
The regulator cleared a sixth supplement to Truqap's original approval, with an updated label issued the following day.
Drugs@FDA
Zhang, formerly Novartis International's Chief Commercial Officer, succeeds interim CEO Alan Bash, who returns to lead the CARVYKTI business.
SEC filing
The Phase III study of Etcamah plus palbociclib showed a numerical but not statistically significant PFS benefit in untreated advanced ER-positive breast cancer.
SEC filing
The agency cleared an efficacy supplement and a related labeling update for the lung cancer drug osimertinib on the same day.
Drugs@FDA (2)
The approval covers Etcamah combined with a CDK4/6 inhibitor for first-line advanced HR-positive, HER2-negative breast cancer patients who develop an ESR1 mutation.
SEC filing
New NDA filing data shows Etcamah is a 75 mg film-coated tablet, approved September 4, 2026, alongside FDA's public announcement.
FDA press release, Drugs@FDA (2)
AstraZeneca and Amgen said the drug showed durable, statistically significant benefits over placebo in eosinophilic esophagitis through week 52.
SEC filing
The trial showed statistically significant progression-free and overall survival gains for ORPATHYS plus TAGRISSO versus chemotherapy in MET-driven resistant NSCLC.
SEC filing
The Phase III study was stopped after monitors found the combination unlikely to beat pembrolizumab on survival measures in low PD-L1 patients.
SEC filing
The company announced a call and webcast on August 14, 2026 featuring its CEO, COO, CFO, and IR head.
SEC filing
Crystalys raised $130 million for dotinurad's Phase 3 program while AstraZeneca reported positive subgroup data for anselamimab, as Fortress's cash balance grew to $196.6 million.
SEC filing
The FDA's target decision date for lorundrostat is December 22, 2026, and Mineralys says commercial launch preparations remain on schedule.
SEC filing
The company finished dosing all patients in the Phase 2 SANRECO trial for divesiran and reported $72.1 million in cash as of June 30, 2026.
SEC filing
AIM says it finished enrollment and dosing in its Phase 2 pancreatic cancer study and expects survival data in 2027, while cash rose to $9.9 million.
SEC filing
Belgium-based Agomab Therapeutics plans to add the two as non-executive directors, pending a shareholder vote in September 2026.
SEC filing
Arcus added three new clinical collaborations for its HIF-2α inhibitor casdatifan and said cash runway extends to at least the second half of 2028.
SEC filing
The company cited new drug approvals and an expanded pipeline as it lifted its full-year Portfolio Receipts outlook to $3,400 million to $3,500 million.
SEC filing
MAIA-ovarian interim data still expected by Q1 2027 as partnered programs advance and net loss narrows to $7.0 million.
SEC filing
The European Commission cleared AstraZeneca and Daiichi Sankyo's Datroway for patients with metastatic triple-negative breast cancer who cannot receive immunotherapy, citing a survival benefit.
SEC filing
The Phase III ALXN1210-TMA-313 study failed on its primary endpoint in adults and adolescents, while a companion pediatric study showed positive survival data.
SEC filing
The European Commission cleared camizestrant plus a CDK4/6 inhibitor for ER-positive, HER2-negative advanced breast cancer patients who develop an ESR1 mutation before disease progression.
SEC filing
The company's chief medical officer will speak on changing treatments in bladder cancer at the BTIG Virtual Biotechnology Conference on July 28, 2026.
SEC filing