<a href="https://www.fiercebiotech.com/biotech/novo-drops-oncology-ambitions-early-stage-mash-prospects-ongoing-rd-shake" hreflang="en">Novo drops oncology ambitions, early-stage MASH prospects in ongoing R&D shake-up</a> Novo Nordisk is winding down a range of early-stage programs for liver disease, oncology and stem cells as part of the Danish Pharma’s ambitious restructuring. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/braveheart-bio-mission-conquer-heart-disease-market-captures-185m-series" hreflang="en">Braveheart Bio launches with mission to conquer heart disease market, capturing $185M series A</a> The hypertrophic-cardiomyopathy-focused biotech is led by former HI-Bio founder and CEO Travis Murdoch, M.D., while Biogen's CEO Chris Viehbacher chairs the board of directors. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/medtech/dexcom-hit-fda-class1-recall-its-continuous-glucose-monitoring-system-app" hreflang="en">Dexcom hit by FDA Class I recall for its continuous glucose monitoring system app</a> Dexcom has been hit by a major safety issue for an Android version of its G6 continuous monitoring system app, leading the FDA to issue its most serious recall notice. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/medtech/precision-neuroscience-inks-partnership-venture-fund-backed-spinal-cord-injury-advocates" hreflang="en">Precision Neuroscience inks partnership with venture fund backed by spinal cord injury advocates</a> Precision Neuroscience’s brain-computer interface—a wireless device that aims to restore function to people with paralysis—is getting a boost from SCI Ventures. The fund is backed by the Christopher & Dana Reeve Foundation and other major spinal cord injury organizations. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/cro/charles-river-announces-cost-cutting-and-strategic-shift-revenue-slide-continues" hreflang="en">Charles River to cuts costs, shift direction as revenue slide continues</a> The board of Charles River Laboratories has completed a strategic review of the company, deciding to cut costs and shift investments into animal testing alternatives and other potential areas of growth. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/ftc-tells-novo-its-metsera-offer-may-violate-us-merger-law-current-form" hreflang="en">FTC warns Novo that current Metsera offer structure may violate US merger law</a> In a letter to lawyers for Novo and Metsera, an FTC official wrote that the proposed purchase of Metsera by the Danish pharma "may violate the procedural provisions" of the Hart-Scott-Rodino (HSR) Act. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/judge-knocks-down-pfizers-efforts-halt-novo-bid-metsera" hreflang="en">Judge knocks down Pfizer's effort to block Novo's rival bid for Metsera</a> Amid the rapidly unfolding saga revolving around Metsera, a judge has denied Pfizer’s request to block Novo Nordisk’s buyout bid for the biotech, Bloomberg reports. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/astrazeneca-drops-phase-2-stage-mash-drug-over-disappointing-data" hreflang="en">AstraZeneca drops MASH drug over disappointing phase 2 data</a> AstraZeneca has ended work on one of its drugs for fatty liver disease after viewing disappointing data from a phase 2 study. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/medtech/icecures-cryoablation-treatment-may-extend-survival-some-lung-cancer-patients-study-finds" hreflang="en">IceCure's cryoablation treatment may extend survival in some lung cancer patients, study finds</a> Last month, IceCure Medical’s tumor-freezing technology won FDA approval for treating early-stage breast cancer. Now, the Israel-based medtech is touting a new study showing its procedure combined with radiation may extend survival for patients with an inoperable form of lung cancer. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/dynavax-pays-vaxart-25m-oral-covid-19-vaccine-program" hreflang="en">Dynavax pays Vaxart $30M for oral COVID-19 vaccine program</a> Dynavax is paying $30 million upfront for global rights to Vaxart’s investigational oral COVID-19 vaccine candidate, positioning the biotech to see phase 2b data before placing a bigger bet on the program. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/inflammation-biotech-evommune-heads-nyse-150m-ipo" hreflang="en">Inflammation biotech Evommune heads to NYSE with $150M IPO</a> Evommune is heading to the New York Stock Exchange this morning via a $150 million IPO that the inflammation biotech will use to fund a pair of clinical-stage candidates. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/modernas-norovirus-phase-3-study-heads-north-again-after-struggling-find-cases" hreflang="en">Moderna's phase 3 norovirus study heads north again after struggling to find cases down south</a> First, the phase 3 trial of Moderna’s norovirus vaccine had to endure a clinical hold. Now, the study has to head back for a second season in the Northern Hemisphere after failing to find enough cases down south. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/eli-lilly-links-amylin-agonist-20-weight-loss-sparking-charge-phase-3" hreflang="en">Eli Lilly links amylin agonist to 20% weight loss, sparking charge into phase 3</a> Eli Lilly has linked its amylin agonist eloralintide to up to 20.1% weight loss at Week 48, encouraging the drugmaker to prepare to enter phase 3 next month. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/medtech/registrar-snaps-cmc-medical-devices-expand-global-compliance-offering" hreflang="en">Registrar snaps up CMC Medical Devices to expand global compliance offering</a> Registrar Corp., a unit of Paine Schwartz Partners, acquired Spanish medical device consulting services provider CMC Medical Devices, expanding the U.S.-based compliance specialist's global reach. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/medtech/illumina-shares-rise-china-set-lift-sequencer-export-ban" hreflang="en">Illumina shares rise as China set to lift sequencer export ban</a> China is set to ease restrictions on some Illumina products, giving the sequencing giant a partial reprieve. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/urogen-hands-anti-ctla4-back-agenus-after-being-unimpressed-phase-1-data" hreflang="en">UroGen hands anti-CTLA-4 drug back to Agenus after being unimpressed with phase 1 data</a> UroGen is handing an anti-CTLA-4 antibody back to Agenus after concluding that phase 1 data for the bladder cancer drug didn’t reach the benchmark for further development. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/axsome-adds-astrazeneca-epilepsy-candidate-pipeline-through-avenue-subsidiary-acquisition" hreflang="en">Axsome adds AstraZeneca epilepsy candidate to pipeline through Avenue subsidiary acquisition</a> Axsome Therapeutics has wrapped its hands around an epilepsy candidate from AstraZeneca through an acquisition of Avenue Therapeutics' subsidiary Baergic Bio, in a deal potentially worth more than $83 million. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/cullinan-sidelines-pair-oncology-assets-amid-expansion-autoimmune-rd" hreflang="en">Cullinan sidelines pair of oncology assets amid expansion into autoimmune R&D</a> More than a year and a half into Cullinan Therapeutics’ pivot from a CD19-focused oncology company to a hybrid autoimmune player, the biotech is parting ways with a pair of cancer programs. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/biotech/fda-announces-second-round-priority-voucher-winners-including-glp-1-leaders-lilly-and-novo" hreflang="en">FDA reveals 2nd round of 'national priority' voucher winners, including obesity giants Lilly and Novo</a> The FDA has released the second batch of recipients for the new "national priority voucher" program, with executives for two of the beneficiaries appearing in the Oval Office with President Donald Trump Nov. 6. FierceBiotech November 7, 2025 Original source
<a href="https://www.fiercebiotech.com/regulatory/shutdown-tracker-cms-issues-billing-guidance-hhs-furloughs-32000-employees" hreflang="en">How the shutdown impacts healthcare: Judge rebukes Trump admin, orders Nov. SNAP benefits paid in full</a> The federal government entered a shutdown Oct. 1 after Republicans and Democrats refused to compromise on their funding asks. FierceBiotech November 7, 2025 Original source