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  • Crystalys mines $130M series B to push gout drug through phase 3
    Crystalys Therapeutics has raised $130 million in series B financing to advance the development of its gout drug dotinurad and prepare for a potential commercial launch.
    Fierce Biotech · 1mo agoNeutral↗ source
  • Eli Lilly’s $3.8 B bid for AtaiBeckley signals strong pharma endorsement of psychedelics
    Eli Lilly has announced a proposed acquisition of AtaiBeckley valued at up to $3.8 billion. Analysts at H.C. Wainwright described the move as the clearest strategic validation to date of psychedeli…
    BioSpace · 1mo agoDealPositive↗ source
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Infectious Disease360
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 1mo agoApprovalPositive↗ source
  • Tempus acquires Personalis for $1.5 billion to expand cancer genomics and MRD testing
    Tempus announced it will purchase Personalis in a transaction valued at $1.5 billion, giving it full ownership of the cancer‑genomics firm. The deal builds on a 2023 partnership where Tempus inves…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Vertex’s IgA nephropathy drug povetacicept gains momentum as FDA reviews it after Novartis and Vera approvals
    Vertex Pharmaceuticals’ povetacicept is currently under FDA review with a target action date of Nov. 30 for the treatment of IgA nephropathy. The FDA recently granted full approval to Novartis’ Fa…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Scribe Therapeutics targets $96 million IPO to fund PCSK9 gene-silencing program
    Scribe Therapeutics, a Bay Area biotech focused on genetic medicines, filed with the SEC outlining plans for an initial public offering on Nasdaq. The company aims to sell 7.1 million shares at $1…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • UK regulator reports rise in drug approvals and new AI healthcare regulations
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines in the past year…
    raps · 1mo agoRegulatoryPositive↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 1mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps to regulate AI in healthcare
    The Medicines and Healthcare products Regulatory Agency (MHRA) presented its 2025-2026 annual report to Parliament, highlighting a higher number of new drug approvals compared with the previous yea…
    raps · 1mo agoRegulatoryPositive↗ source
  • Axiom Biosciences to launch IPO on Hong Kong exchange before Nasdaq co‑listing
    San Diego‑based Axiom Biosciences announced plans to go public with a primary listing on the Hong Kong Stock Exchange, followed later by a Nasdaq co‑listing, a structure it says is a first for a U.…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA’s push to publish complete response letters faces legal uncertainty and possible pause
    The FDA began releasing complete response letters (CRLs) to the public last year, a move promoted as increasing transparency for drug developers, investors, and patients. However, the policy has e…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Veteran scientists launch nonprofit Center for Therapeutic Genetics to advance personalized gene therapies
    A group of experienced researchers from top institutions has created the nonprofit Center for Therapeutic Genetics (CTG) to develop personalized genetic medicines. CTG will operate from a modest s…
    Fierce Biotech · 1mo agoPositive↗ source
  • BMS partners with Nvidia to build the largest AI supercomputer for drug research
    Bristol Myers Squibb announced an expanded partnership with Nvidia aimed at creating the biggest AI‑driven supercomputing platform for its drug discovery and development work. The new system will…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune disease
    Kyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Kolon’s cell-based gene therapy misses key endpoints in phase 3 osteoarthritis trial
    Kolon TissueGene reported that its phase 3 study of TG‑C, a cell‑based gene therapy for knee osteoarthritis, failed to meet its co‑primary endpoints. Patients receiving the therapy showed no statis…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Latigo Biotherapeutics plans IPO to fund phase 3 trials of non-opioid pain drug LTG-001
    Latigo Biotherapeutics announced it is preparing an initial public offering to raise capital for its clinical-stage, non-opioid pain management pipeline. The company highlighted its oral Nav1.8 in…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Geopolitical uncertainty dampens UK biotech IPO outlook despite record Q2 venture funding
    Geopolitical uncertainty continues to weigh on the sentiment around initial public offerings for British biotech companies, according to an industry leader speaking to Fierce. At the same time, th…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Abbott reports cyberattack on cancer diagnostics and LabCentral portal, says operations unaffected
    Abbott announced that a cyber incident on July 16 accessed a limited number of internal systems in its cancer diagnostics unit. The company said the breach does not affect product availability, ma…
    Fierce Biotech · 1mo agoNegative↗ source
  • Eli Lilly’s $2.8 bn purchase of AtaiBeckley adds psychedelic candidate BPL‑003, sparking optimism for broader mental‑health drug pipeline
    Eli Lilly announced it has acquired AtaiBeckley for $2.8 billion, bringing the privately held biotech’s lead psychedelic program into its portfolio. The deal gives Lilly access to BPL‑003, an intr…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 1mo agoApprovalPositive↗ source
  • Abbott Beats Q2 Expectations with Strong Device and Diagnostic Sales, Raises Profit Forecast
    Abbott reported second‑quarter results that exceeded analysts' forecasts, easing concerns about potential impact of ACA subsidy cuts on medtech firms. Diagnostics revenue jumped 42% year‑over‑year…
    Fierce Biotech · 1mo agoEarningsPositive↗ source
  • Dimerix acquires Mission's phase-2 ready AKI drug in $292 million deal
    Dimerix announced it has acquired the acute kidney injury candidate MTX652 from Mission Therapeutics in a deal valued at up to $292 million, including a $5 million upfront payment. Mission had com…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • India’s life-sciences sector faces scaling hurdles despite rapid innovation growth, report says
    India’s life‑sciences sector has shown rapid growth, according to a new report by Boston Consulting Group and HealthKois. Patent filings have risen more than four‑fold since 2016, the pipeline of i…
    BioSpace · 1mo agoNeutral↗ source
  • GSK drops chronic cough drug camlipixant after mixed Phase 3 results
    GSK announced it will stop investing in camlipixant for refractory chronic cough after the drug failed to meet key endpoints in a late-stage trial. The company had run two Phase 3 studies, CALM-1…
    BioSpace · 1mo agoNegative readoutNegative↗ source