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924 stories matching this filter · ← front page

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  • Bicara appoints President Ryan Cohlhepp as CEO effective Jan. 1, while J&J veteran John Reed joins Madrigal board
    Bicara Therapeutics announced a leadership transition, naming its current President and COO Ryan Cohlhepp as the new chief executive officer effective Jan. 1. Cohlhepp will take over the role as t…
    Endpoints · 3h agoNeutral↗ source
  • MapLight presses the pause button; ADC Therapeutics considers what to do with Zynlonta
    ⏸️ MapLight Therapeutics pauses preclinical and discovery work: The biotech said it will instead focus its resources on advancing its lead candidate, ML-007C-MA, for schizophrenia and Alzheimer’s d…
    Endpoints · 22m ago↗ source
  • FDA grants accelerated approval to Bristol Myers' iberdomide for relapsed or refractory multiple myeloma
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The U.S. Food and Drug Administration has issued an accelerated approval for iberdomide, a small-molecule therapy developed by Bristol Myers Squibb. The approval targets patients with multiple mye…
Endpoints · 17h agoApprovalPositive↗ source
  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • European regulators withdraw Amgen's Tavneos over questionable data
    European regulators announced they are pulling Amgen's rare disease drug Tavneos from the European market after reviewing data they deemed incorrect and misleading. The authorities said the data s…
    Endpoints · 19h agoRegulatoryNegative↗ source
  • FDA's PDUFA VIII adds 'America First' incentives and speeds up drug reviews
    The Food and Drug Administration announced the next five‑year reauthorization of the Prescription Drug User Fee Act, known as PDUFA VIII. The agency said the new framework will introduce several po…
    Endpoints · 20h agoRegulatoryPositive↗ source
  • Karyopharm faces default risk with only a month left to rescue cancer expansion
    Karyopharm Therapeutics, a commercial-stage cancer drugmaker, is confronting severe financial strain as its market capitalization is roughly one‑third of the revenue it expects to generate in 2026.…
    Endpoints · 23h agoNegative↗ source
  • Khartis Therapeutics secures $50 million Series B funding from Forge Life Science Partners, Longwood Fund and Lilly Asia Ventures
    San Diego-based Khartis Therapeutics announced a $50 million Series B financing round. The round was led by Forge Life Science Partners and included participation from Longwood Fund, Lilly Asia Ve…
    Endpoints · 1d agoDealPositive↗ source
  • PTC Therapeutics and Eli Lilly to acquire parts of bankrupt Sangamo for up to $264 million
    The gene-editing company Sangamo Therapeutics has filed for bankruptcy, placing its assets up for sale. An auction process has identified two bidders: PTC Therapeutics and Eli Lilly, which togethe…
    Endpoints · 1d agoDealNeutral↗ source
  • FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in China
    The U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…
    raps · 1d agoRegulatoryNeutral↗ source
  • Aligned Marketplace secures $20 million to link self-insured employers with primary-care clinics
    Aligned Marketplace is a health‑tech startup that matches self‑insured employers with primary‑care clinics, helping companies provide direct access to medical services for their workers. The compa…
    Endpoints · 1d agoDealPositive↗ source
  • Baxter recalls Duo-Vent IV solution sets over risk of air bubbles in patients
    Baxter has issued a recall of its Duo-Vent solution sets and male Luer lock adapters after the FDA identified a risk that the devices could contain air bubbles in the drip chamber and tubing. The…
    fda medwatch · 1d agoCRLNegative↗ source
  • European trade group urges authorities to grant notified bodies access to Eudamed for risk-based oversight
    A trade association representing notified bodies has formally asked EU regulators to allow them to access the Eudamed database. The group says that such access would enable them to apply the risk-…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA releases draft PDUFA VIII commitment letter outlining goals and enhancements for 2028-2032
    The FDA on Thursday issued a proposed commitment letter for the upcoming PDUFA VIII cycle, which will cover fiscal years 2028 through 2032. The letter sets out the agency's performance targets for…
    raps · 1d agoRegulatoryNeutral↗ source
  • Epilepsy drug from Ovid and Takeda receives fresh start under Perceptive-backed venture
    After about 26 months since two Phase 3 trials failed, the epilepsy treatment candidate originally developed by Ovid Therapeutics and Takeda has been removed from their pipelines. Investment firm…
    Endpoints · 20h agoDealNeutral↗ source
  • FDA grants emergency use authorization for Simparica TRIO to treat New World screwworm in dogs and puppies
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Simparica TRIO, a chewable tablet containing sarolaner, moxidectin and pyrantel, to treat New World screwworm infesta…
    fda press · 21h agoRegulatoryPositive↗ source
  • Experts warn of deaths linked to Neurocrine's Vykat XR for Prader-Willi syndrome
    A coalition of specialists in Prader-Willi syndrome has raised serious concerns about the safety profile of Neurocrine Biosciences' drug Vykat XR. The experts point to a series of adverse events,…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • AbCellera, Silence and InduPro secure major funding rounds as AbCellera completes $200M share sale
    Vancouver based biotech AbCellera announced a $200 million share offering after meeting its efficacy targets in a Phase 2 hot flashes trial. The capital raise follows the company achieving its pred…
    Endpoints · 1d agoDealPositive↗ source
  • FDA outlines new onshoring incentives and meeting types for generic drug applicants under GDUFA IV
    The FDA released its GDUFA IV commitments, indicating that review timelines for generic drug submissions will remain largely consistent through 2032, mirroring the schedule of the previous five yea…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • Boulevard Bio raises $65M to expand immunology pipeline, eyes Vera's IgAN candidate
    Boulevard Bio announced it has secured $65 million in financing to broaden its immunology portfolio. The new capital will support the development of two immune‑resetting drugs the company discovere…
    Endpoints · 2d agoDealPositive↗ source
  • Medline issues correction for convenience kits containing recalled ICU Medical pain management components
    Medline announced a correction for certain convenience kits that include ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection. The FDA classified…
    fda medwatch · 2d agoCRLNegative↗ source
  • FDA issues early alert on non-sterile BD ChloraPrep applicators in Medline convenience kits
    The FDA's Center for Devices and Radiological Health (CDRH) released an early alert about a potential high‑risk issue with certain Medline convenience kits that contain BD ChloraPrep applicators th…
    fda medwatch · 2d agoRegulatoryNeutral↗ source
  • Eli Lilly sues six U.S. firms over alleged black-market sales of investigational drug retatrutide
    Eli Lilly has filed lawsuits against six U.S. companies it says are selling its investigational diabetes and weight-loss drug retatrutide. The companies are accused of operating a black-market for…
    Endpoints · 1d agoNegative↗ source
  • FDA releases proposed commitment letter detailing changes to GDUFA IV program
    The U.S. Food and Drug Administration has issued a proposed commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV). The letter follows several months o…
    raps · 2d agoRegulatoryNeutral↗ source