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268 stories matching this filter · ← front page

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  • Trump administration eyes Heidi Overton as next FDA commissioner
    President Donald Trump is reported to be preparing a nomination for Heidi Overton to become the next commissioner of the Food and Drug Administration, according to multiple news outlets. Overton i…
    BioPharma Dive · 23h agoRegulatoryNeutral↗ source
  • AstraZeneca’s Tagrisso plus Orpathys improves survival in MET-mutated lung cancer
    A new combination therapy using AstraZeneca’s Tagrisso together with Hutchmed’s Orpathys has shown a survival benefit for patients with a specific form of non‑small cell lung cancer. The study focu…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
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Infectious Disease346
  • FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax
    Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.
    BioPharma Dive · 3d agoApprovalPositive↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of bispecific antibody volrustomig after interim data miss survival goal
    AstraZeneca announced termination of the Phase 3 study of its experimental bispecific antibody volrustomig in non‑small cell lung cancer. An interim data review by trial monitors indicated the dru…
    BioPharma Dive · 2d agoNegative readoutNegative↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 6d agoRegulatoryPositive↗ source
  • Taiho and Cullinan report positive Phase 3 results for zipalertinib in EGFR exon 20 insertion lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their experimental drug zipalertinib achieved positive results in a Phase 3 trial for first‑line treatment of lung cancer patients whose tumo…
    BioPharma Dive · 6d agoPositive readoutPositive↗ source
  • Boulevard Bio launches with $65 million to develop bispecific antibodies for IgA nephropathy and other autoimmune diseases
    Boulevard Bio, a new biotech co-founded by autoimmune researcher Georg Schett and former Sanofi CSO Frank Nestle, announced its launch on Wednesday with $65 million in funding. The company’s first…
    BioPharma Dive · 8d agoDealPositive↗ source
  • Former Legend Biotech CEO Ying Huang appointed head of K2 Therapeutics as startup secures $50M seed funding
    Ying Huang, who led Legend Biotech for seven years and helped develop a top‑selling cell therapy for multiple myeloma, has been named chief executive of K2 Therapeutics. The young company, founded…
    BioPharma Dive · 8d agoDealPositive↗ source
  • Vaderis raises $152 million to launch late-stage trials of AKT inhibitor engasertib for rare bleeding disorder
    Vaderis Therapeutics announced a $152 million Series B financing round, giving it sufficient capital to advance its experimental AKT-targeting drug, engasertib. The company has also begun late-sta…
    BioPharma Dive · 9d agoDealPositive↗ source
  • Revolution Medicines sees strong demand for pancreatic cancer drug daraxonrasib under compassionate use
    Revolution Medicines reports that more than 2,000 patients have received its pancreatic cancer candidate daraxonrasib through a compassionate use program. The company says the drug has been distri…
    BioPharma Dive · 13d agoPositive↗ source
  • Bristol Myers Squibb expands Nvidia partnership to build most powerful AI supercomputer for drug discovery
    Bristol Myers Squibb announced an expanded partnership with Nvidia that will give it the most powerful and energy-efficient Nvidia infrastructure owned by a life-science company. Nvidia says the p…
    BioPharma Dive · 13d agoDealPositive↗ source
  • Latigo Biotherapeutics raises $345.6M in IPO to fund non-opioid pain drug pipeline
    Latigo Biotherapeutics, a Los Angeles-based biotech focused on non-opioid ion-channel-blocking pain therapies, completed an initial public offering on Thursday. The company sold 19.2 million share…
    BioPharma Dive · 13d agoDealPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 13d agoApprovalPositive↗ source
  • Replimune's oncolytic virus therapy Tudriqev receives FDA accelerated approval for advanced melanoma
    The U.S. Food and Drug Administration has granted approval to Replimune's melanoma treatment, ending a series of earlier rejections after an advisory panel advocated for the drug. The therapy, pre…
    BioPharma Dive · 13d agoApprovalPositive↗ source
  • Cardiac biotech Braveheart raises $382.5M in IPO, launches on Nasdaq as BRVE
    Braveheart Bio, a cardiac drug developer, priced its initial public offering on Wednesday and secured $382.5 million in proceeds. The company sold about 21.2 million shares at $18 each, exceeding t…
    BioPharma Dive · 14d agoDealPositive↗ source
  • Gilead reports modest sales rise but analysts question future growth beyond HIV drugs
    Gilead's second‑quarter results showed total product revenue of $7.6 billion, up 8% year‑over‑year. The company's two leading HIV treatments, Biktarvy and Descovy, together generated about $5.7 bi…
    BioPharma Dive · 14d agoEarningsNeutral↗ source
  • J&J pharma chief Jennifer Taubert to retire; Krystal Biotech shares plunge after gene therapy revenue shortfall
    Johnson & Johnson announced that Jennifer Taubert will step down as head of its pharmaceutical division after a 21‑year tenure. During her time she oversaw commercial strategy, dealmaking and the…
    BioPharma Dive · 16d agoNegative↗ source
  • Pfizer expands cost-cutting program, targeting $1 billion in new savings through 2029
    Pfizer announced it is expanding a cost-cutting initiative first launched in 2023 to further reduce expenses. The new measures are projected to generate about $1 billion in additional savings by 2…
    BioPharma Dive · 15d agoNeutral↗ source
  • Wall Street reacts negatively to AstraZeneca-Bristol Myers merger talks, shares tumble
    A report in the Financial Times, followed by Reuters, said AstraZeneca and Bristol Myers Squibb have been discussing a possible combination in recent months. The news triggered a sharp sell-off. A…
    BioPharma Dive · 16d agoDealNegative↗ source
  • BioNTech appoints Sobi head Guido Oelkers as new CEO to steer oncology shift
    BioNTech announced that Guido Oelkers, who has led the rare‑disease focused Swedish company Sobi since 2017, will become its next chief executive officer. Oelkers is slated to take over the role b…
    BioPharma Dive · 16d agoNeutral↗ source
  • Johnson & Johnson secures option to acquire in-vivo CAR-T developer Sail Biomedicines for up to $2.6 billion
    Johnson & Johnson announced a strategic partnership with Sail Biomedicines, a Flagship Pioneering‑backed startup, that includes an upfront cash payment and an equity investment. The initial paymen…
    BioPharma Dive · 20d agoDealPositive↗ source
  • FDA advisory panel backs Replimune's melanoma therapy RP1, raising approval prospects
    Advisors to the U.S. Food and Drug Administration voted 10-3 in favor of Replimune's experimental melanoma treatment, RP1, despite lingering scientific concerns about the data presented. The panel…
    BioPharma Dive · 20d agoRegulatoryPositive↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 21d agoEarningsPositive↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 21d agoRegulatoryNegative↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 21d agoDealNeutral↗ source