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  • Samsung Biologics to acquire Swiss CDMO PolyPeptide for $1.8 billion, entering peptide API market
    Samsung Biologics announced a plan to purchase Swiss contract development and manufacturing organization PolyPeptide for $1.8 billion in cash. The acquisition will extend Samsung Biologics' manufa…
    Endpoints · 24d 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 · 24d agoRegulatoryPositive↗ source
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  • 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 · 25d 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 · 25d 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 · 25d agoRegulatoryPositive↗ source
  • Anthropic ramps up biopharma push with Nobel hires and M&A plans
    Anthropic, known for its artificial‑intelligence models, is expanding its focus to life sciences after a detailed internal memo outlined the move. The memo, released in late 2024, named biology an…
    Endpoints · 24d agoPositive↗ 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 · 24d agoRegulatoryNegative↗ source
  • UK biotech venture capital funding hits record high in Q2 2026, surpassing any full year since 2022
    UK biotech companies secured more venture capital in the second quarter of 2026 than they did in any full calendar year since 2022. The surge reflects a broader fundraising revival, with investors…
    Endpoints · 24d agoDealPositive↗ source
  • Bristol Myers Squibb partners with Nvidia to build pharma's most advanced AI supercomputer
    Bristol Myers Squibb announced it will construct what it calls the most advanced and energy-efficient AI supercomputer system in the biopharma sector. The project will be carried out in partnershi…
    Endpoints · 24d 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 · 24d agoRegulatoryPositive↗ source
  • UnitedHealth outlines AI rollout as quarterly results beat expectations
    UnitedHealth Group, a major health insurer, announced a substantial investment in artificial intelligence earlier this year. The company recently detailed how the technology is being integrated in…
    Endpoints · 24d agoPositive↗ source
  • House lawmakers support US trade panel's probe into China's biotech sector and pricing practices
    At least ten members of the U.S. House of Representatives have voiced support for a trade investigation targeting China’s biotechnology industry. The investigation, led by a U.S. trade panel, will…
    Endpoints · 24d agoRegulatoryNeutral↗ source
  • J&J and AbbVie also considered AtaiBeckley before Lilly’s $2.8 B acquisition
    Johnson & Johnson and AbbVie were reported to have evaluated AtaiBeckley as a potential target in the psychedelic market. The companies did not submit an offer before Eli Lilly closed its $2.8 bil…
    Endpoints · 24d agoDealNeutral↗ source
  • Scribe targets $96 million from Nasdaq IPO as Scholar Rock awaits site classification for apitegromab
    Scribe, a gene-editing biotech, announced plans for a Nasdaq initial public offering that could raise roughly $96 million. The company said it would price the shares at $14 each, which is the midp…
    Endpoints · 24d agoDealNeutral↗ 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 · 25d agoRegulatoryNeutral↗ source
  • Biogen reports mixed Alzheimer’s trial results as industry sees new startup launches
    Biogen released data from its Alzheimer’s program that showed mixed outcomes, indicating some signals but also setbacks. The weekly newsletter also highlighted the launch of two new biotech startu…
    Endpoints · 26d agoNeutral↗ source
  • BlossomHill and Latigo lead a surge of biotech IPOs after summer dry spell
    After a seven‑month lull that left no biotech companies on the public markets last summer, the sector is seeing renewed activity. BlossomHill Therapeutics and Latigo have filed to list on Nasdaq,…
    Endpoints · 27d agoDealPositive↗ source
  • Mid-size biotech firms urge White House to scrap CMS GLOBE and GUARD pricing proposals
    A group of midsized biotechnology companies met with officials from the White House and the Department of Health and Human Services this week. The companies presented a coordinated case to senior p…
    Endpoints · 27d agoRegulatoryNegative↗ source
  • Celcuity's Revtorpyk receives FDA approval, but launch delay pushes stock lower
    The FDA announced approval of Celcuity’s oncology candidate Revtorpyk on Tuesday, marking the company’s first cancer drug clearance. Analysts had broadly expected the approval and had priced the s…
    Endpoints · 27d agoApprovalNeutral↗ 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 · 27d agoNeutral↗ source
  • GSK to launch large trial testing shingles vaccine’s potential to reduce Alzheimer’s risk
    GSK announced it will conduct a large-scale clinical study to evaluate whether the shingles vaccine can lower the risk of developing Alzheimer’s disease. The move follows observations from analyses…
    Endpoints · 27d agoNeutral↗ source
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 27d agoDealPositive↗ source
  • GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
    Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
    BioSpace · 27d ago↗ source
  • Insmed moves closer to $6B opportunity as PAH drug shows long-term durability
    Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements thro…
    BioSpace · 27d ago↗ source
  • FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking
    Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…
    BioSpace · 27d ago↗ source