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The targeted drug release device TAR-200 shows promising response and disease-free survival rates in specific populations of patients with non-muscle-invasive bladder cancer.
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Analysts expressed skepticism about plans detailed by Moderna’s R&D chief Stephen Hoge to trim research spending in preparation for the launch of up to 10 new products.
As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline.
No patients have received Casgevy, CRISPR Therapeutics and Vertex Pharmeceuticals’ recently approved sickle cell gene therapy. Experts weigh in on the path to profit for the treatment and the therapeutic class in general.
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Eli Lilly and Company announced the extension of the expiration of the tender offer to acquire all of the issued and outstanding shares of common stock of POINT Biopharma Global Inc., for a purchase price of $12.50 per share in cash, without interest and less any applicable tax withholding.
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The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
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The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness.
The World Health Organization names antimicrobial resistance as one of the most urgent public health threats, but it remains an unattractive target for the pharmaceutical industry due to its weak profitability.
President Trump also refused to promise pharma execs that he would hamstring the IRA’s drug negotiation program.
Ctexli’s approval further entrenches Mirum as a leader in rare liver diseases, alongside its cornerstone product Livmarli and upcoming drug volixibat.
Drug development powered by artificial intelligence is countering incentives from the Inflation Reduction Act and making small molecules more attractive in the complex inflammatory & immunology disease space.
Around 300 FDA staffers laid off last week are being asked to return. So far, the Trump administration has terminated some 1,000 employees from the agency.
Non-opioid pain therapies are entering an unprecedented era, marked by the landmark FDA approval of Vertex’s Journavx and a growing number of alternative approaches. Their ultimate uptake, however, remains to be seen.
With the modality now in early clinical trials, experts say more efficiency, broader editing capabilities and delivery breakthroughs are needed to propel RNA editing to the next stage.
The proposed acquisition by global investment firms Carlyle and SK Capital Partners could net shareholders $3 per share plus potential CVR dollars and provide bluebird bio with primary capital to expand the commercial reach of its gene therapies.
Acelyrin earlier this month agreed to an all-stock merger with fellow immune player Alumis, with their combined cash tiding the combined company over until 2027.