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145 stories matching this filter · ← front page

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  • Denali Therapeutics' Avlayah generates $3.6M in Q1, beating forecasts
    Denali Therapeutics reported that its newly launched Hunter syndrome therapy Avlayah earned $3.6 million in revenue during the first quarter after its April market entry. Analysts had projected ro…
    BioSpace · 6h agoPositive readoutPositive↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 2h agoLayoffsNegative↗ source
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Endocrinology & Metabolism318
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Pain306
Infectious Disease299
  • FDA issues alert in wake of BD recall of faulty needle sets that caused four deaths
    The FDA’s Center for Devices and Radiological Health issued an early alert for Becton Dickinson’s Intraosseous Vascular Access system needle sets in the wake of four deaths and 45 serious injuries…
    Fierce Biotech · 9h ago↗ source
  • Silence brings the noise to Takeda with phase 2 blood cancer win
    A phase 2 trial of Silence Therapeutics’ divesiran has hit its primary endpoint, emboldening the biotech to gear up for late-phase development of a potential challenger to Takeda and Protagonist Th…
    Fierce Biotech · 12h ago↗ source
  • Ensoma cuts staff again to focus on lead gene therapy for rare immune disease
    Boston‑based biotech Ensoma announced another round of layoffs as it narrows its efforts to its sole clinical candidate, EN‑374, aimed at treating X‑linked chronic granulomatous disease (X‑CGD). E…
    Fierce Biotech · 3d agoLayoffsNegative↗ source
  • Braveheart Bio raises $382.5M in IPO to fund phase 3 trial of cardiac drug
    Braveheart Bio, a San Francisco biotech, completed an IPO that raised $382.5 million, exceeding its original target. The company increased the share count to 21.2 million and set the price at $18…
    Fierce Biotech · 4d agoDealPositive↗ source
  • BioVie shares plunge as Parkinson’s trial results lack primary motor data
    BioVie reported results of its Phase 2 SUNRISE-PD study in early‑stage Parkinson’s disease. The double‑blind, placebo‑controlled trial enrolled 57 patients who had not yet received carbidopa/levodo…
    BioSpace · 3d agoNegative readoutNegative↗ source
  • Novo Nordisk reports mixed trial results for CagriSema and ziltivekimab, cites setbacks and seeks bolt-on deals
    Novo Nordisk's chief executive said the company has experienced "a couple of setbacks" after recent trial data. The phase 3 study of ziltivekimab, an IL‑6 ligand antibody, did not show a statistica…
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • AstraZeneca and BMS deny merger talks, Reuters says no deal
    Reuters reported that rumors of a merger between AstraZeneca and Bristol Myers Squibb have been dismissed. A senior source close to the matter told Reuters there is no deal and no discussions betw…
    BioSpace · 5d agoDealNeutral↗ source
  • Novo Nordisk CEO says innovation is essential as pipeline faces setbacks
    During Novo Nordisk's second-quarter earnings call, CEO Maziar Mike Doustdar said that failure is a normal part of drug development and emphasized that the company's survival depends on continual i…
    BioSpace · 5d agoEarningsNeutral↗ source
  • Merger talks between Bristol Myers Squibb and AstraZeneca fade as Q2 earnings roll out and FDA advisory meetings heat up
    Talks of a possible merger between Bristol Myers Squibb and AstraZeneca have receded after analysts highlighted antitrust hurdles. Both companies, each valued over $130 billion, were rumored to con…
    BioSpace · 5d agoDealNeutral↗ source
  • Novo Nordisk CFO describes roller-coaster growth and stays optimistic about CagriSema after Q2 earnings
    Novo Nordisk CFO Karsten Munk Knudsen talked to Fierce after the company released its second-quarter earnings, reflecting on his nine-year tenure and the firm’s volatile performance. He recalled a…
    Fierce Biotech · 5d agoEarningsNeutral↗ source
  • Five BioSpace NextGen companies debut on US markets in 2026, four actively hiring
    BioSpace NextGen honorees accounted for about one third of the 14 U.S. biotech companies that went public in 2026. The five companies together raised roughly $1.5 billion in IPO proceeds, includin…
    BioSpace · 5d agoPositive↗ source
  • Pfizer CEO says $7 billion cash ready for bolt‑on acquisitions and dividend will stay intact
    During its second‑quarter earnings call, analysts asked Pfizer if the company would increase M&A spending as rivals rush to buy biotech assets. CEO Albert Bourla replied that Pfizer currently has…
    BioSpace · 5d agoDealPositive↗ source
  • Pfizer adds $2.5 billion to restructuring, targeting $6 billion savings by 2029
    Pfizer announced an additional $2.5 billion in cost reductions as part of its ongoing restructuring program. The new cuts focus on technology and simplification across commercial, R&D and manufact…
    BioSpace · 6d agoNegative↗ source
  • As portfolio erodes, BMS stands to gain a lot from rumored AstraZeneca merger
    While both drugmakers face looming patent cliffs, analysts say joining forces could help Bristol Myers Squibb replenish its eroding portfolio—while the strategic case for AstraZeneca seems to be mo…
    BioSpace · 6d agoDealNeutral↗ source
  • BioNTech appoints Sobi CEO Guido Oelkers as new chief, founders to launch separate mRNA biotech
    BioNTech announced that Guido Oelkers, current chief executive of Swedish Orphan Biovitrum (Sobi), will assume the role of CEO in early 2027. The move follows the earlier decision of co‑founders U…
    BioSpace · 7d agoNeutral↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 7d agoCRLNegative↗ source
  • Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk
    The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
    fda medwatch · 10d agoCRLNegative↗ source
  • BMS beats Q2 forecasts and lifts 2026 outlook despite delays in Cobenfy and milvexian data
    BMS reported second‑quarter revenue of $12.97 billion, topping analysts' estimate of $11.73 billion, and earnings per share of $2.04, well above the $1.60 consensus. The strong results prompted the…
    BioSpace · 11d agoEarningsNeutral↗ source
  • Bristol Myers pushes Cobenfy Alzheimer’s psychosis readout to early 2027 after enrollment delays
    Bristol Myers Squibb said the Phase 3 readout for its Cobenfy Alzheimer’s psychosis program will be postponed to early 2027. The company had previously expected data from the three Adept trials to…
    Fierce Biotech · 11d agoNegative readoutNegative↗ source
  • Biogen’s early Phase 2 data supports tau-targeting Alzheimer’s approach
    Biogen has released early Phase 2 results for its experimental Alzheimer’s therapy diranersen, indicating that reducing tau protein levels may lead to cognitive benefits. The findings add to a lon…
    BioSpace · 11d agoPositive readoutPositive↗ source
  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 11d agoDealPositive↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 11d agoRegulatoryNegative↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 12d agoApprovalPositive↗ source