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334 stories matching this filter · ← front page

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  • Bristol Myers appoints Cristian Massacesi as head of R&D as Robert Plenge exits
    Bristol Myers Squibb announced a reorganization of its research and development organization, merging the research and development units under a single leader. Cristian Massacesi, currently chief…
    BioPharma Dive · 7h agoNeutral↗ source
  • BioNTech spends $205 million on FDA priority review voucher to accelerate oncology pipeline
    BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher, a tool that can shorten the agency's standard review period from ten months to six months. The voucher was previo…
    Fierce Biotech · 1d agoDealPositive↗ source
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Ophthalmology1074
Endocrinology & Metabolism782
Pain780
Nephrology764
  • Flagship-backed Valo Health merges with Montai Therapeutics to boost AI-driven drug pipeline
    Valo Health and Montai Therapeutics announced they will combine under the Valo brand, creating a larger AI-focused biotech aimed at accelerating early-stage drug discovery. Valo, launched in 2020…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Novocure's Optune Mya device denied FDA approval over efficacy concerns
    Novocure received a "not approvable" letter from the FDA for its Optune Mya system, which was being evaluated for patients with brain metastases from non‑small cell lung cancer after stereotactic r…
    Fierce Biotech · 2d agoRegulatoryNegative↗ source
  • Windward Bio targets $204M Nasdaq IPO to fund Chinese respiratory drug program
    Windward Bio, a biotech backed by Sanofi, announced plans to go public on Nasdaq with an offering of 10.3 million shares priced between $16 and $18 each. The company expects net proceeds of about $…
    Fierce Biotech · 3d agoDealNeutral↗ source
  • Kyorin signs $140M deal for Japan rights to Edesa's ARDS antibody
    Kyorin Pharmaceutical will pay $12 million up front and up to $134 million in milestones, plus royalties, for exclusive Japan rights to Edesa Biotech’s anti‑TLR4 antibody, paridiprubart, intended f…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Chinese biotech CEOs target creation of up to ten global Big Pharma firms within a decade
    Chinese drug developers have shifted from generic manufacturing to aiming for a seat at the global Big Pharma table, according to recent interviews. The country now ranks second after the United S…
    Fierce Biotech · 5d agoPositive↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 6d agoApprovalPositive↗ source
  • Onchilles reports that direct tumor injection of N17350 clears distant lesions in solid tumor models
    Onchilles, a San Diego biotech, presented data on its therapeutic elastase N17350, a vaccine‑like agent injected directly into solid tumors. In preclinical studies the intratumoral injection not o…
    Fierce Biotech · 6d agoPositive readoutPositive↗ source
  • Medicare to slash 340B drug payments and expand site-neutral rules in 2027
    Medicare finalized a rule that will cut payments for drugs covered by the 340B discount program and broaden site-neutral payment policies beginning in 2027. The rule is expected to reduce Medicare…
    BioPharma Dive · 7d agoRegulatoryNegative↗ source
  • J&J and AbbVie present early trispecific antibody data for multiple myeloma at ASH meeting
    At the American Society of Hematology (ASH) meeting, Johnson & Johnson and AbbVie are slated to share early clinical data on trispecific antibodies targeting multiple myeloma. These next‑generation…
    BioPharma Dive · 7d agoPositive readoutPositive↗ source
  • Boehringer Ingelheim strikes $7.4 billion deal with Sino Biopharma for preclinical ADC and TCE programs
    Boehringer Ingelheim announced a major licensing agreement with China's Sino Biopharmaceutical, paying $358 million upfront for a six‑program option covering preclinical antibody‑drug conjugates an…
    Fierce Biotech · 8d agoDealPositive↗ source
  • Philips earmarks $322 million for pending DOJ settlement on sleep-apnea device recall
    Philips' Respironics division announced it has reached an agreement in principle with the U.S. Department of Justice to settle the investigation into its sleep‑apnea device recall. The recall, ini…
    Fierce Biotech · 9d agoRegulatoryNegative↗ source
  • UniQure slated for FDA decision by May 1 as analysts see potential for first Huntington’s disease therapy
    UniQure said the Food and Drug Administration has set a decision date for its Huntington's disease gene therapy and is likely to hold an advisory committee meeting. The agency indicated a faster‑th…
    BioPharma Dive · 9d agoRegulatoryNeutral↗ source
  • Pfizer drops phase 2 pulmonary arterial hypertension candidate amid pipeline cut
    Pfizer has discontinued its phase 2 pulmonary arterial hypertension (PAH) program, PF-07868489, citing business reasons rather than safety or efficacy concerns. The drug, which targets BMP9 inhibi…
    Fierce Biotech · 9d agoNegative↗ source
  • AbbVie halts development of livmoniplimab after deeming benefit limited
    AbbVie announced it is discontinuing the phase 2 development of its monoclonal antibody livmoniplimab (ABBV-151) after concluding the drug is unlikely to outperform existing therapies. The drug wa…
    Fierce Biotech · 9d agoNegative↗ source
  • Biossil Labs acquires Theriva's antibiotic-degrader portfolio in up to $91 million deal
    Biossil Labs, a Canadian biotech backed by OpenAI, announced a deal to acquire Theriva Biologics' early- to mid-stage portfolio of antibiotic‑degrading enzymes for a total potential value of up to…
    Fierce Biotech · 10d agoDealNeutral↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 10d agoDealNeutral↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 13d agoEarningsPositive↗ source
  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 13d agoDealPositive↗ source
  • Molecular Partners to cut up to 44% of staff as it shifts focus to radiotherapy pipeline
    Molecular Partners announced it will lay off up to 44% of its workforce, affecting as many as 55 positions, as the Swiss biotech redirects its limited cash toward a radiotherapeutic program. The c…
    Fierce Biotech · 13d agoLayoffsNegative↗ source
  • Bambusa Therapeutics exceeds IPO target raising $169 million, while Aspen Neuroscience falls short with $141 million
    Bambusa Therapeutics announced that its initial public offering was upsized, selling more shares at the midpoint of its $15‑$17 range and raising about $168.9 million, exceeding the $150.4 million…
    Fierce Biotech · 13d agoDealNeutral↗ source
  • Roche launches VENTANA BAP1 test to improve mesothelioma diagnosis
    Roche announced the global launch of its VENTANA BAP1 (SP527) test, an automated ready‑to‑use immunohistochemistry assay designed for differential diagnosis of mesothelioma. The assay targets the…
    Fierce Biotech · 13d agoPositive↗ source
  • Merck says 2027 will focus on pipeline and new product launches despite recent trial wins
    Merck's chief financial officer said the company views 2027 as another year of investment, emphasizing its expanding pipeline and upcoming product launches rather than short‑term margin growth. Th…
    Fierce Biotech · 14d agoEarningsNeutral↗ source
  • Eli Lilly consolidates US and international sales under new global markets unit as veteran exec retires
    Eli Lilly announced that long‑time executive Patrik Jonsson will retire after 36 years with the company. Jonsson has been serving as executive vice president and president of Lilly International, o…
    Fierce Biotech · 14d agoNeutral↗ source