FDA
FDA Cleared Filspari for FSGS Despite Phase 3 Fail, Opening $2B Market
FDA cleared Filspari for focal segmental glomerulosclerosis on Monday, making Travere Therapeutics' endothelin blocker the first and only approved drug for…
Latest — Page 37
Deals
Alamar Biosciences Files $159M IPO on 196% Revenue Growth
Alamar Biosciences wants $159 million from public markets, pricing 9.4 million shares at $15 to $17 apiece for a Nasdaq listing under "ALMR.
Legal
Filed: DOJ Moves to Block Rovirosa Release Before Hoyt's Dismissal
The DOJ asked U.S. District Court Judge Kenneth Hoyt in the Southern District of Texas to stay his forthcoming dismissal order in the foreign bribery…
FDA
IDEAYA Files FDA: Darovasertib Doubles PFS to 6.9 Months
Darovasertib, IDEAYA Biosciences and Servier's PKC inhibitor for metastatic uveal melanoma, more than doubled median progression-free survival in its Phase…
FDA
Ideaya Eye Cancer Drug Hits Phase 3, Files Accelerated NDA
Ideaya Biosciences cleared its own late-stage success benchmark for a rare eye cancer drug, and the company now plans to file for accelerated approval with FDA.
Deals
Click Therapeutics Cut More Than a Quarter of Staff After Series D
Click Therapeutics raised Series D funding, then cut more than a quarter of its workforce shortly after.
FDA
Beats Venetoclax: Lilly's Jaypirca Posts 4th Phase 3 Win in CLL
Jaypirca chalked up its fourth positive phase 3 readout in chronic lymphocytic leukemia on Monday, and this one rewrites the treatment calculus: it's the…
Deals
AbbVie Bought Two NaV1.8 Pain Assets from Haisco for $745M
AbbVie bought ex-China rights to two NaV1.8 sodium channel pain inhibitors from Beijing-based Haisco Pharmaceutical for up to $745 million.
Deals
Kailera Files $528.5M Nasdaq IPO to Fund Four GLP-1 Obesity Drugs
Kailera filed for a $528.5 million Nasdaq IPO, pricing 33.33 million shares at $14 to $16 each.
FDA
Revolution Medicines' Daraxonrasib Succeeds in Phase 3 Registrational Trial
Daraxonrasib succeeded in a Phase 3 registrational trial for pancreatic cancer patients, Revolution Medicines reported Monday.
FDA
Cleared Phase 3: Daraxonrasib Hits 13.2-Month OS in Pancreatic Cancer
Daraxonrasib cleared both primary endpoints in a phase 3 trial for previously treated metastatic pancreatic cancer, Revolution Medicines reported April 13.
Deals
Regeneron Paid $40M to Enter Radiopharma; Telix Scores Up to $4.3B
Regeneron put $40 million on the table Sunday to partner with Telix Pharmaceuticals, the Australian biotech with one of the more active radiopharmaceutical…
FDA
Darovasertib Hits 6.9-Month PFS Goal, Ideaya Plans H2 FDA Filing
Darovasertib cleared its primary endpoint in a phase 2/3 trial in metastatic uveal melanoma, posting median progression-free survival of 6.9 months against…
FDA
GSK Races mo-rez Into 5 Phase 3 Trials After 62% Ovarian ORR
GSK is sending mocertatug rezetecan (mo-rez) into five phase 3 trials after phase 1b data posted a 62% confirmed overall response rate in platinum-resistant…
FDA
FDA Cleared Foundayo; Lilly Pre-Stocked $1.5B Before Approval
FDA cleared Foundayo eight days ago, and Eli Lilly was ready: the company pre-stocked $1.5 billion worth of the pill back in February, months before…
