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Revolution Medicines' RAS Inhibitor Cleared in Five Weeks & Spyre's TL1A Antibody Misses in Rheumatoid Arthritis
Revolution Medicines filed on July 22nd and had FDA approval just over a month later — a five-week review for a pancreatic cancer drug that nearly do…
3 weeks, 2 days ago
Jazz’s HER2 Bispecific Wins First-Line Gastric & McKesson Pays $2.25B for Precision Medicine
The FDA cleared Jazz Pharmaceuticals' Ziihera (zanidatamab) in first-line HER2-positive gastroesophageal adenocarcinoma with median overall survival …
3 weeks, 3 days ago
Regenxbio Plunges 26% as FDA Halts Hunter Gene Therapy & Capricor Duchenne Decision Slips to Nov. 22 on Narrower Label
Regenxbio shares plunged 26% to $7.96 after the FDA placed a second clinical hold on RGX-121 (clemidsogene lanparvovec) — but the real trigger was th…
3 weeks, 4 days ago
Week in Review | AstraZeneca Kills Volrustomig Lung Trial, Discloses No Data
AstraZeneca pulled its Phase 3 volrustomig lung trial at interim review — and released no efficacy data at all. The eVOLVE-Lung02 study tested the PD…
3 weeks, 5 days ago
Akeso's Third ADC: What "Differentiated" Still Has to Prove & Leads Biolabs Puts 4-1BB Back on the Board
Akeso cleared AK157D1, a B7-H3 antibody-drug conjugate, into Phase 1 in solid tumors — its third differentiated ADC, and a late entry into an already…
3 weeks, 6 days ago
Daily Roundup | Moderna and Merck's mRNA Cancer Vaccine Wins Phase 3 — But There's No Filing Date
Intismeran autogene plus KEYTRUDA met its primary and key secondary endpoints in the 1,137-patient Phase 3 INTerpath-001 melanoma trial — the first P…
4 weeks, 1 day ago
Daily Roundup | Heidi Overton FDA Pick: What It Means for Approvals
Trump names Heidi Overton to lead the FDA — and a Republican senator calls part of her record almost disqualifying on day one. We break down the conf…
4 weeks, 2 days ago
Daily Roundup | Amylyx Avexitide Wins Phase 3: 55% Fewer Hypoglycemic Events, Filing at Stake
Amylyx's avexitide cut serious hypoglycemic events 55% in Phase 3, sending shares up 54% to a three-year high - on a drug bought for $35 million out …
1 month ago
Daily Roundup | EyePoint Crashes 67% After Duravyu Fails Phase 3 in Wet AMD
EyePoint stock crashed 67% after Duravyu missed its primary endpoint against aflibercept in the LUGANO Phase 3 for wet AMD - with nine vision-loss ca…
1 month ago
Week in Review | Lilly's Retatrutide Lawsuits: Enforcing a Drug Nobody Has Approved
Eli Lilly filed six lawsuits over black-market retatrutide and has referred more than 200 sellers to regulators — before it has even filed for approv…
1 month ago