Archive snapshot · Biotech
Sat, Sep 26, 8:03 PM ET
Mirum and Incyte win FDA approval of Atebrioz (zilurgisertib) for ultra-rare bone disorder FOP
The approval intensifies competition with Regeneron in the small market for fibrodysplasia ossificans progressiva, a disorder that causes abnormal bone growth.
Fierce Pharma · +4 outlets
FDA approves Eli Lilly's once-weekly basal insulin Onswik for adults with type 2 diabetes
A weekly injection gives patients an alternative to daily long-acting insulin, a large convenience shift in a crowded diabetes market.
STAT · +14 outlets
FDA approves Belzutifan combo (Welireg) for advanced kidney cancer without proven survival benefit
The two-pill regimen expands options in advanced renal cell carcinoma even as regulators and analysts question the absence of an overall survival gain.
inkl.com · +13 outlets
Merck and Daiichi Sankyo withdraw FDA application for ifinatamab deruxtecan
The withdrawal sets back one of the partners' closely watched antibody-drug conjugate programs.
Mugglehead Investment Magazine · +14 outlets
Tolebrutinib becomes first EU-approved disability-targeting therapy for nonrelapsing secondary progressive MS
The European clearance opens a new treatment class for an MS subtype that has had few options.
NeurologyLive · +8 outlets
Moderna stock hits multi-year highs as Bernstein calls intismeran clearest mRNA platform validation
Investor enthusiasm around Moderna's cancer vaccine and reported UAE investment talks drove shares to a four-year peak.
The Crypto Basic · +7 outlets
Genentech strikes $1.5B+ deal with AI firm Earendil for cancer bispecifics
The partnership adds to a wave of large pharma bets on AI-driven drug discovery for oncology.
BioSpace · +1 outlets
Legends Biotech reports CARVYKTI delivered five-year treatment-free remissions in 50% of early-line myeloma patients
The long-term data bolsters the case for earlier use of the CAR-T therapy in relapsed or refractory multiple myeloma.
The Manila Times · +3 outlets
FDA approves lirafugratinib for advanced bile duct cancer
The targeted therapy adds an option for a rare and hard-to-treat cancer with limited treatments.
Labroots · +13 outlets
Advisers narrowly back adding six peptides to the drug compounding list
The vote shapes the availability of compounded peptides, a contentious area of pharmacy regulation.
AJMC · +12 outlets
FDA grants Prime Medicine green light for gene editing study
The clearance advances a next-generation gene editing program into clinical testing.
Benzinga · +7 outlets
RNAi specialist ADARx raises $446M in IPO
It is the first U.S. RNAi biotech IPO in more than a decade, a notable test of public market appetite for RNA medicines.
Biopharmadive · +3 outlets
NIH funding cuts delayed a childhood brain cancer trial, CNBC reports
The story illustrates how federal research budget reductions are slowing trials for patients with few alternatives.
CNBC · +4 outlets
Lilly signs $3.35B InnoCare deal as China lays out a five-year biotech plan
The transaction highlights surging Western interest in Chinese biotech assets amid policy and geopolitical scrutiny.
Fierce Pharma · +2 outlets
Blood test for cancer wins FDA advisers' backing
Advisory support for a multi-cancer blood test moves the screening approach closer to wider clinical use.
13WMAZ · +12 outlets
Promising mRNA cancer vaccine tested at Penn
The personalized vaccine results are being watched as a test of the mRNA platform beyond infectious disease.
Inquirer.com · +14 outlets
Basecamp Research raises $140M to advance AI-designed medicines
The round adds to a streak of large fundraises for AI drug discovery startups.
Indian Pharma Post · +1 outlets
Cereno Scientific reports positive Phase I PK data for CS014, targeting Phase IIb in PH-ILD
The results support a direct move toward mid-stage testing in pulmonary hypertension with interstitial lung disease.
TradingView · +1 outlets

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