Gabrielle Masson

Cycle Pharmaceuticals is circling up Applied Therapeutics, acquiring the rare disease biotech after an extremely tumultuous year for the latter that began with an FDA rejection at the end of 2024.< | Cycle Pharmaceuticals is circling up Applied Therapeutics, acquiring the rare disease biotech after an extremely tumultuous year for the latter that began with an FDA rejection at the end of 2024.

After a year marked by dramatic ups and downs, William Blair analysts say 2026 could carry forward the industry’s current momentum—as long as strong clinical data continue to be rewarded and compan | After a year marked by dramatic ups and downs, William Blair analysts say 2026 could carry forward the industry’s current momentum—as long as strong clinical data continue to be rewarded and companies can bring drugs to market without major government pricing regulations.

Formation Bio is inking a deal worth more than $600 million in biobucks for ex-China rights to a next-gen immunology asset from Lynk Pharmaceuticals. | Formation Bio is inking a deal worth more than $600 million in biobucks for ex-China rights to a next-gen immunology asset from Lynk Pharmaceuticals.

Two affiliates of Apple Tree Partners have filed for bankruptcy, a move designed to continue funding the venture firm's portfolio biotechs as a funding dispute with a top investor plays out. | Two affiliates of Apple Tree Partners have filed for bankruptcy, a move designed to continue funding the venture firm's portfolio biotechs as a funding dispute with a top investor plays out.

The FDA has qualified its first artificial intelligence tool to help drug developers evaluate fatty liver disease in their clinical trials. | The FDA has qualified its first AI tool to help drug developers evaluate fatty liver disease in clinical trials.

The FDA’s reported plan to move toward single-trial approvals has stirred industry concern, but one group of analysts views the proposal as a catalyst for greater R&D investment in the sector.< | The FDA’s reported plan to move toward single-trial approvals has stirred industry concern, but one analyst views the proposal as a catalyst for greater R&D investment in the sector.

The industry’s mRNA alliance is demanding steady FDA leadership, warning that the current “unprecedented turmoil” at the agency is eroding Americans' trust and threatening public health.  | The industry’s mRNA alliance is demanding steady FDA leadership, warning that the current “unprecedented turmoil” at the agency is eroding Americans' trust and threatening public health.

Paradigm Health has raised $78 million as it works to revamp the clinical research ecosystem, while also announcing a deal to acquire Flatiron Health's clinical research business unit.  | Paradigm Health has raised $78 million as it works to revamp the clinical research ecosystem, while also announcing a deal to acquire Flatiron Health's clinical research business unit.

The FDA has proposed cutting fees for early-stage companies conducting clinical development in the U.S. instead of abroad. | The FDA has proposed cutting fees for early-stage companies conducting clinical development in the U.S. instead of abroad.

Almost exactly one year ago, Janux Therapeutics unveiled ea | Almost exactly one year ago, Janux Therapeutics unveiled early data for its investigational T-cell engager that wowed investors and analysts alike. But the biotech’s newest update has failed to garner the same investor enthusiasm, with the company’s stock nearly halved following the data drop.

Artificial intelligence is booming across biopharma, with deployed tech taking aim at the industry’s biggest challenges: the significant risk of failure, high costs and long development timelines.< | Artificial intelligence is booming across biopharma, with deployed tech taking aim at the industry’s biggest challenges: the significant risk of failure, high costs and long development timelines.

French vaccine developer Valneva is closing down a site that houses both operational and R&D work, impacting 30 employee roles. | French vaccine maker Valneva is closing down a site that houses both operational and R&D work, impacting 30 employee roles.

A federal commission is warning that the U.S. | A federal commission is warning that the U.S. is losing its innovative edge, arguing that the nation needs to “reimagine the federal science enterprise” by streamlining funding and incorporating AI into processes.

AbbVie is opening submissions for an award that will provide one Canadian biotech with free access to lab space and executive insights from the Big Pharma. | AbbVie is opening up submissions for an award that will provide one Canadian biotech free access to lab space and executive insights from the Big Pharma.

VC Versant Ventures is unveiling Dayra Therapeutics, a new biotech working on oral macrocyclic peptide drugs—a mission that has already reeled in a partnership with Biogen. | VC Versant Ventures is unveiling Dayra Therapeutics, a new biotech working on oral macrocyclic peptide drugs—a mission that has already reeled in a partnership with Biogen.

Swedish biotech Sprint Bioscience is selling off an early-stage TREX1 cancer pr | Swedish biotech Sprint Bioscience is selling off an early-stage TREX1 cancer program to Gilead for $14 million upfront, plus the chance to net up to $400 million in biobucks.

A drug safety group has delivered a positive analysis for a Sarepta Therapeutics-licensed RNA medicine, with the same study also hitting an enrollment target, triggering a $200 milestone payment du | A drug safety group has delivered a positive analysis for a Sarepta-licensed RNA medicine, with the same study also hitting an enrollment target. The latter development has triggered a $200 milestone payment due to Arrowhead Pharmaceuticals.

The CDC is instructing scientists to end all research involving monkeys by the end of the year, in a move that will impact around 200 macaques and an unknown number of studies,

Hundreds of industry leaders have signed a letter to FDA Director Marty Makary, M.D., about the importance of having a predictable regulatory agency, citing a survey in which 82% of biopharma respo | Hundreds of industry leaders have signed a letter to FDA Director Marty Makary, M.D., about the importance of having a predictable regulatory agency, citing a survey in which 82% of biopharma respondents said they were concerned about the FDA’s ability to function.

Contineum Therapeutics’ M1 receptor antagonist has failed to move the needle in a phase 2 vision test for patients with a common form of multiple sclerosis. | Contineum Therapeutics’ M1 receptor antagonist has failed to move the needle in a phase 2 vision test for patients with a common form of multiple sclerosis.