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1,937 stories matching this filter · ← front page

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  • Pfizer reports positive Phase 3 results for Elrexfio in relapsed multiple myeloma
    Pfizer announced that its antibody-drug conjugate Elrexfio achieved a statistically significant and clinically meaningful improvement in progression-free survival for patients with relapsed or refr…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Chiesi to acquire KalVista for $1.9 billion, adding oral hereditary angioedema drug Ekterly to its rare-disease portfolio
    Chiesi Group announced it will purchase KalVista Pharmaceuticals for $1.9 billion, gaining ownership of Ekterly, an oral on‑demand treatment for hereditary angioedema (HAE). Ekterly received FDA a…
    BioPharma Dive · 4mo agoDealPositive↗ source
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  • FDA pilots real-time clinical trials as Amgen, AstraZeneca join proof-of-concept studies; AbbVie eyes KRAS biotech Kestrel
    The U.S. Food and Drug Administration announced a pilot program for "real-time" clinical trials, designed to cut the lag between data collection and regulatory review. AstraZeneca and Amgen have l…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • GSK CEO warns possible team reorganization if upcoming Phase 3 readouts fall short
    GSK's chief executive Luke Miels told analysts during the first‑quarter earnings call that the company has several pivotal Phase 3 trials slated for this year. He said that if those late‑stage rea…
    Endpoints · 4mo agoNeutral↗ source
  • AbbVie's Skyrizi sales growth raises investor worries about J&J competition
    During AbbVie's first-quarter earnings call, analysts focused on the company's immunology franchise and asked how it would defend Skyrizi against emerging competition from Johnson & Johnson. The c…
    Endpoints · 4mo agoEarningsNegative↗ source
  • FDA schedules first oncology advisory panel in nine months, will review AstraZeneca candidates
    The FDA announced it will hold an oncology advisory committee meeting roughly nine months from now. The meeting will focus on evaluating a pair of investigational drugs from AstraZeneca, though de…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Bristol Myers Squibb faces identity crisis as CEO Chris Boerner enters make-or-break year
    Bristol Myers Squibb is at a strategic crossroads as its chief executive, Chris Boerner, approaches the midway point of his tenure. After roughly two and a half years in the role, Boerner has over…
    Endpoints · 4mo agoNegative↗ source
  • Biogen seeks early-stage pipeline deals after $5.6 billion Apellis acquisition
    Biogen announced it has earmarked $5.6 billion to acquire Apellis Pharmaceuticals, a move completed earlier this month. Despite the large transaction, the company says it will continue to explore…
    Endpoints · 4mo agoDealPositive↗ source
  • AstraZeneca lifts UK investment pause, pledges £300 million for new office expansion
    AstraZeneca announced on Wednesday that it is ending its pause on UK investment and will allocate £300 million to complete construction of a new office facility. The funding is intended to expand t…
    Endpoints · 4mo agoDealPositive↗ source
  • Chiesi to acquire KalVista Pharmaceuticals for $1.9 billion in cash deal
    Italian pharma Chiesi announced it will purchase commercial biotech KalVista Pharmaceuticals. The transaction is valued at about $1.9 billion, with Chiesi paying $27 per share in cash. The acquis…
    Endpoints · 4mo agoDealPositive↗ source
  • AstraZeneca halts several mid- and late-stage trials after efficacy setbacks
    AstraZeneca announced it has stopped a number of mid- and late-stage clinical trials in its pipeline over recent months. The decision follows disappointing efficacy results in those studies, limit…
    Endpoints · 4mo agoNegative↗ source
  • Teva nabs experimental Tourette drug in $700M Emalex buyout
    A Jefferies analyst argued the deal — Teva’s largest in a decade — “makes sense” given the synergies between Emalex and the pharmaceutical giant’s neurology business.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • AI researcher Kyunghyun Cho leaves Genentech to explore pharma applications at Endpoints AI Day
    Kyunghyun Cho, a noted AI researcher, announced that he has left Genentech to pursue independent work in pharmaceutical applications of machine learning. He will discuss his new focus at Endpoints…
    Endpoints · 4mo agoPositive↗ source
  • MPM BioImpact adds three China-origin drug programs to K2 Therapeutics portfolio
    MPM BioImpact, a biotech investment firm, is intensifying its "best of both worlds" approach by bringing drug candidates that originated in China to a broader market. Over the past year its portfo…
    Endpoints · 4mo agoDealPositive↗ source
  • Pfizer settles with generics to extend tafamidis patent until 2031, protecting revenue
    Pfizer announced settlements with three generic manufacturers-Dexcel Pharma, Hikma Pharmaceuticals and Cipla-to delay the launch of generic versions of tafamidis, the active ingredient in its rare‑…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Boehringer’s dual-acting obesity shot survodutide meets primary goal in Phase 3, showing strong weight loss and muscle-preserving effect
    Boehringer Ingelheim announced that its dual-acting injectable obesity therapy, survodutide, achieved its primary endpoint in a Phase 3 study. Participants receiving the drug lost significantly mo…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • FDA urges Amgen to withdraw Tavneos after alleging data manipulation by former developer
    The FDA has sent a formal letter to Amgen recommending that the company pull its drug Tavneos from the market. The agency says new information shows the original approval filings from ChemoCentryx…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source
  • FDA says trial manipulation undermines approval of ChemoCentryx's Tavneos, now owned by Amgen
    The U.S. Food and Drug Administration has announced that it believes the pivotal trial supporting the approval of Tavneos was manipulated. The agency says ChemoCentryx, which was acquired by Amgen…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Incyte reports positive Phase 3 results for povorcitinib in nonsegmental vitiligo, plans FDA filing
    Incyte announced that its oral JAK1 inhibitor povorcitinib achieved positive outcomes in two Phase 3 trials targeting nonsegmental vitiligo. The studies met their primary endpoints, demonstrating…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • AbbVie eyes pan-RAS market with up to $1.45 B option to acquire Kestrel
    AbbVie announced it has signed an agreement that gives it the right to acquire Kestrel Therapeutics for up to $1.45 billion. The deal would give AbbVie access to Kestrel’s pipeline focused on pan-…
    Endpoints · 4mo agoDealPositive↗ source
  • BridgeBio's heart drug Attruby exceeds sales expectations, shifting investor outlook
    BridgeBio prepared to sell its heart drug Attruby on its own, prompting skepticism from investors and analysts who doubted the company could compete with larger rivals. The drug far outperformed f…
    BioPharma Dive · 4mo agoPositive↗ source
  • Novartis CEO warns of impact from Germany's €60 billion healthcare spending cuts
    Novartis chief executive Vas Narasimhan said the company is very disappointed by Germany's proposal to reduce healthcare spending by more than €60 billion. He expressed concern that the cuts could…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • FDA launches pilot to collect real-time clinical trial data
    The FDA announced a new pilot program that will gather clinical trial information as it is generated, allowing reviewers to see data in real time. The agency says this approach could speed up eval…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Pfizer secures two-year extension on Vyndamax patent, delaying competition
    Pfizer announced it has obtained an extension that pushes back the start of generic competition for its heart-failure drug Vyndamax (tafamidis) by about two years. Vyndamax ranks among Pfizer’s to…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Supreme Court to hear arguments on generic fish‑oil pill case, industry watches
    The U.S. Supreme Court is set to hear arguments this week on a case involving a prescription‑strength pill derived from fish oil. The dispute centers on whether the product qualifies as a generic…
    Endpoints · 4mo agoRegulatoryNeutral↗ source