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1,374 stories matching this filter · ← front page

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  • AstraZeneca says AI has yet to yield clinical candidates but could lower risk in late-stage trials
    AstraZeneca's chief executive Pascal Soriot told reporters that the company's AI‑driven efforts in drug design have not yet produced a candidate that has entered clinical testing. He added that th…
    Endpoints · 17d agoNeutral↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, adding anti‑CD122 antibody program
    Argenx announced a $2.2 billion cash transaction to purchase Forte Biosciences, a biotech focused on autoimmune therapies. The acquisition brings Forte's anti‑CD122 monoclonal antibody, which is c…
    Endpoints · 17d agoDealPositive↗ source
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  • Argenx to acquire Forte Biosciences for $2.2 billion, securing phase-2 vitiligo antibody FB102
    Argenx announced it will buy Forte Biosciences for $2.2 billion, gaining access to FB102, an anti‑CD122 antibody currently in phase‑2 trials for vitiligo and celiac disease. In a recent phase 1b s…
    Fierce Biotech · 17d agoDealPositive↗ source
  • Virginia judge orders FDA to revisit Biden-era mifepristone restrictions
    A federal judge in Virginia has ruled that the FDA must reexamine certain restrictions on the abortion medication mifepristone that were put in place during the previous administration. The judge…
    Endpoints · 17d agoRegulatoryNeutral↗ source
  • Fujifilm Biotech CEO warns CDMOs must expand services ahead of looming patent cliff
    Fujifilm Biotechnologies CEO Lars Petersen said drugmakers are gearing up for a looming biopharma patent cliff in 2026, a situation that could pressure revenue streams as key patents expire. He wa…
    Endpoints · 17d agoNeutral↗ source
  • FDA questions efficacy of Capricor's Duchenne muscular dystrophy cell therapy ahead of advisory committee
    FDA reviewers have raised concerns about the efficacy of Capricor's cell therapy for Duchenne muscular dystrophy as the agency prepares for an advisory committee meeting. The agency said it could n…
    Endpoints · 17d agoRegulatoryNegative↗ source
  • FDA says Capricor's DMD cell therapy failed to meet Phase 3 endpoints
    The FDA briefing documents released before an advisory committee meeting state that the Phase 3 trial of Capricor's deramiocel did not achieve its pre-specified primary and secondary efficacy endpo…
    BioSpace · 17d agoRegulatoryNegative↗ source
  • MapLight's schizophrenia drug fails primary endpoint in Phase 2, sending stock down over 60%
    MapLight Therapeutics saw its shares tumble more than 60% after a mid‑stage trial showed that its once‑daily schizophrenia candidate did not meet the primary efficacy endpoint, even though the over…
    Endpoints · 17d agoNegative readoutNegative↗ source
  • Sarepta appoints former AbbVie R&D chief Michael Severino as new CEO amid DMD regulatory outlook
    Sarepta Therapeutics announced that Michael Severino, who previously led Tessera Therapeutics and served as AbbVie’s head of research and development, will become the company’s chief executive. Sev…
    BioSpace · 17d agoPositive↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, adding anti-CD122 antibody FB102
    Argenx announced it will buy Texas‑based Forte Biosciences in a transaction valued at roughly $2.2 billion. The offer of $77 per share represents an 86 % premium to Forte’s recent average price. T…
    BioSpace · 17d agoDealPositive↗ source
  • Schrödinger launches AI agent Bunsen, CEO admits earlier AI skepticism was wrong
    Schrödinger announced the debut of its new AI agent, Bunsen, which is built on the company’s physics‑based software platform. The tool is intended to help biopharma researchers model molecular beha…
    Endpoints · 17d agoPositive↗ source
  • Apnimed targets up to $160 million IPO to fund launch of Oxnimbi, its oral sleep apnea pill
    Apnimed, a Massachusetts biotech, filed with the SEC indicating it will seek an IPO of up to $160 million to finance the commercial launch of its oral obstructive sleep apnea therapy, Oxnimbi (AD10…
    Fierce Biotech · 17d agoDealPositive↗ source
  • MapLight shares tumble over 60% after mixed Phase 2 schizophrenia trial results
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the experimental schizophrenia drug ML-007C-MA, causing its stock to fall sharply. The trial enrolled 307 patients wi…
    Fierce Biotech · 17d agoNegative readoutNegative↗ source
  • InnoCare’s oral TYK2 inhibitor fadeucravacitinib meets primary endpoint in phase 3 psoriasis trial
    InnoCare Pharma announced that its oral TYK2 inhibitor fadeucravacitinib (also known as ICP-488) achieved the primary endpoint in a phase 3 study of adults with moderate-to-severe plaque psoriasis.…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • Denmark's foundation-driven biotech surge pulls Swedish startups across the Øresund, outpacing Nordic peers
    Denmark, and in particular its capital Copenhagen, is emerging as the leading biotech hub in the Nordic region, outpacing its neighbours in investment and talent development. Swedish biotech start…
    BioSpace · 17d agoPositive↗ source
  • Lilly, AbbVie and others pursue in-vivo CAR-T, but safety concerns loom
    Analysts at H.C. Wainwright say safety will be the decisive factor for in‑vivo CAR‑T therapies, noting that convenience and efficacy alone will not win over investors. In‑vivo CAR‑T aims to genera…
    BioSpace · 17d agoNeutral↗ source
  • Summit Therapeutics reports positive Phase 3 data for lung cancer drug ivonescimab, highlighting regulatory hurdles for US approval
    Summit Therapeutics and its Chinese partner Akeso announced that their PD-1/VEGF antibody ivonescimab showed positive results in a Phase 3 trial for non-small cell lung cancer in Western patients.…
    BioSpace · 17d agoPositive readoutPositive↗ source
  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 17d agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA advisory panel lifts restrictions on six wellness peptides
    The FDA's advisory committee concluded its two-day meeting by voting to remove the existing limits on six widely used health and wellness peptides. Committee members said the vote overrode earlier…
    Endpoints · 17d agoRegulatoryPositive↗ source
  • MapLight’s schizophrenia pill hits primary endpoint but falls short of challenging BMS’s Cobenfy
    MapLight Therapeutics reported results from its Phase 2 ZEPHYR trial of the oral muscarinic agonist ML-007C-MA in schizophrenia. The trial met its primary endpoint, showing a statistically signifi…
    BioSpace · 17d agoPositive readoutNeutral↗ source
  • Gossamer Bio regains rights to lung disease asset from Chiesi after Phase 3 failure, eyes FDA submission
    Gossamer Bio announced that it has taken back the rights to its inhaled pulmonary hypertension candidate from partner Chiesi after the drug failed to meet its primary endpoint in a Phase 3 trial.…
    BioSpace · 17d agoNegative readoutNeutral↗ source
  • MapLight’s schizophrenia drug misses primary endpoint in Phase 2, shares tumble over 60%
    MapLight Therapeutics reported results from a mid‑stage Phase 2 trial of its experimental schizophrenia therapy. The study evaluated a once‑daily dosing regimen and failed to meet the predefined p…
    Endpoints · 17d agoNegative readoutNegative↗ source
  • Gossamer ends $486M PAH partnership with Chiesi after phase 3 miss
    Gossamer Bio announced it is terminating its collaboration and licensing agreement with Italy's Chiesi, regaining worldwide development and commercial rights to its pulmonary arterial hypertension…
    Fierce Biotech · 17d agoDealNegative↗ source