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  • BioNTech's gotistobart shows 18.5-month median survival in relapsed squamous lung cancer, beating docetaxel
    BioNTech presented updated data from its phase 3 Preserve-003 trial at the World Conference on Lung Cancer in Seoul. The trial compares its anti-CTLA-4 antibody gotistobart with standard chemothera…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • GSK’s risvutatug rezetecan shows 18.5-month median overall survival in phase 3 SCLC trial
    GSK, together with Chinese partner Hansoh Pharma, reported results of its antibody‑drug conjugate risvutatug rezetecan (ris‑rez) in a phase 3 trial for relapsed small‑cell lung cancer. The study e…
    Fierce Biotech · 1mo agoPositive readoutPositive
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  • Definium Therapeutics clinches third phase-3 win for LSD anxiety drug, eyes FDA filing
    Definium Therapeutics reported another successful phase 3 trial of its LSD‑based anxiety treatment, DT120 ODT. The Panorama study enrolled 245 patients and compared a 100 µg dose of DT120 with pla…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Novartis shares tumble 13% after three late-stage drug setbacks hit market
    Novartis' stock dropped more than 13% this week after three of its late-stage programs reported setbacks, pulling down other pharma stocks. The antibody-oligonucleotide conjugate del-desiran faile…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Revolution Medicines secures FDA approval for Rasonque, a RAS inhibitor targeting advanced pancreatic cancer
    Revolution Medicines announced FDA approval of its RAS inhibitor Rasonque for patients with advanced pancreatic cancer, marking a milestone for the company. The approval is seen as a breakthrough…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • Novartis board under fire as two late-stage trials fail and CAR-T program paused
    Novartis' board is facing heightened investor scrutiny after the Swiss drugmaker reported failures in two pivotal late-phase trials, raising doubts about its capital deployment strategy for growth…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Samsung Biologics secures $262 million manufacturing contract with European pharma firm
    Samsung Biologics announced a $262 million agreement to provide manufacturing services to an unnamed European pharmaceutical company. The contract runs through 2033. The deal will be executed at S…
    BioSpace · 1mo agoDealPositive↗ source
  • Frazier Life Sciences raises over $1.1 billion for its small-mid-cap biotech fund, total commitments now $2.8 billion
    Frazier Life Sciences announced that it has added more than $1.1 billion in new capital to its public fund that targets small and mid‑size biopharma companies. The infusion brings the fund's total…
    BioSpace · 1mo agoDealPositive↗ source
  • ALS research pivots to biology-driven biomarkers to capture disease heterogeneity
    ALS drug development is moving beyond traditional measures such as survival time and the ALS Functional Rating Scale. Researchers are now adding biology‑focused approaches that aim to reflect the f…
    Fierce Biotech · 1mo agoPositive↗ source
  • FDA pushes back decision on Exelixis' zanzalintinib and Roche's Tecentriq combo for metastatic colorectal cancer
    The FDA announced a delay in its decision on the approval of Exelixis' oral kinase inhibitor zanzalintinib when used with Roche's Tecentriq for metastatic colorectal cancer. The agency said it nee…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • FDA leadership stabilizes under new CBER and CDER heads and appoints first AI deputy commissioner
    At the Food and Drug Administration, Karim Mikhail and Michael Davis have been confirmed as the permanent heads of the Center for Biologics Evaluation and Research and the Center for Drug Evaluatio…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Owkin and Servier partner to use AI platform K Pro for oncology discovery and trial design
    Owkin, an AI drug-discovery CRO, has entered a new agreement with French pharmaceutical company Servier to license its AI scientist, K Pro, for use in Servier’s oncology research and clinical trial…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA plans study on barriers to women's enrollment in pregnancy exposure registries and announces PRV fee rates
    The Food and Drug Administration said it will conduct research into perceived barriers that limit women’s participation in pregnancy exposure registries. It also released the fee schedule for prio…
    raps · 1mo agoRegulatoryNeutral↗ source
  • BioSpace to Host Webinar on Using Podcasts, Webinars and Thought Leadership for Pharma Marketing
    BioSpace announced a webinar that will walk PR, communications and marketing teams through the use of podcasts, webinars and thought‑leadership programs to raise executive visibility in biotech and…
    BioSpace · 1mo agoNeutral↗ source
  • Novartis shareholder urges board overhaul after costly Avidity acquisition setbacks
    Novartis investor David Samra, managing director at Artisan Partners, told Reuters that the company’s board should be reshaped to improve oversight of its dealmaking activities. He said the board n…
    Fierce Biotech · 1mo agoDealNegative↗ source
  • Encoded Therapeutics secures $275M Series F to advance gene therapy for Dravet syndrome
    Encoded Therapeutics announced a $275 million Series F financing round aimed at moving its lead gene‑therapy candidate, ETX101, toward pivotal trials for Dravet syndrome. In the ongoing Phase 1/2…
    BioSpace · 1mo agoDealPositive↗ source
  • Molecular residual disease testing offers earlier insight into cancer treatment response
    In oncology, determining whether cancer has truly been eliminated after therapy is challenging because imaging and standard clinical criteria often miss low‑level disease. Molecular residual diseas…
    Fierce Biotech · 1mo agoPositive↗ source
  • FDA pauses enrollment in Biohaven's epilepsy trials after earlier depression trial failure
    FDA placed a partial clinical hold on Biohaven's Kv7 potassium channel agonist, BHV-7000 (opakalim), halting enrollment of new patients in two late-stage focal epilepsy studies. The pause follows…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Frazier Life Sciences raises over $1.1 billion for its public biotech fund, now $2.8 billion total
    Frazier Life Sciences announced that its public fund has secured more than $1.1 billion in new capital, bringing the fund’s total assets to $2.8 billion. The fund, launched in 2021, targets small-…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • New FDA Oncology Center chief Angelo de Claro pledges AI integration and trial expansion
    Angelo de Claro, M.D., has taken over as the permanent head of the FDA’s Oncology Center of Excellence after serving as acting director since late 2025. In his first interview, he said the agency w…
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Singapore opens biotech-focused Boston hub, strengthening ties with city
    Singapore announced the opening of its fifth U.S. overseas centre, a biotech-focused hub in Boston, during an event at the historic Raffles Hotel. Government officials and business leaders gathered…
    Fierce Biotech · 1mo agoPositive↗ source
  • Drugmakers Rethink Launch Strategies as MFN Pricing Rules Shake Market
    A new Numerof & Associates report says that the rollout of Most Favored Nation (MFN) pricing rules is forcing drugmakers to overhaul how they choose launch markets. Executives surveyed said the Un…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • FDA places partial hold on Biohaven epilepsy drug BHV-7000 amid $350 million licensing deal
    The U.S. Food and Drug Administration issued a partial clinical hold on enrollment for Biohaven’s epilepsy candidate BHV-7000 after rodent studies raised questions about drug metabolites. The hold…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • Takeda R&D chief Andy Plump to retire after string of recent FDA approvals
    Takeda's long-serving research and development president Andy Plump will step down in June. He joined the Japanese drugmaker in 2015 from Sanofi and has led the R&D organization since then. His ex…
    Fierce Biotech · 1mo agoPositive↗ source
  • FDA proposes 50% fee cut for US early-stage trials, but industry says speed matters more
    The FDA announced a proposal to cut the application fee by half for drugs that run their early-stage trials in the United States. The reduction, about $2.3 million at current rates, is intended to…
    BioSpace · 1mo agoRegulatoryNegative↗ source