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  • 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
  • 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
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  • 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
  • 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
  • AI-driven admin tech continues to dominate health-tech funding landscape
    The article notes that administrative technology remains the leading segment within health‑tech investment. Startups that apply artificial intelligence to automate routine tasks such as patient fol…
    Endpoints · 4mo agoPositive↗ source
  • Boehringer dual-acting obesity shot hits mark in Phase 3 trial
    Survodutide spurred weight loss Wall Street analysts referred to as “Wegovy-like,” and showed signs it might help preserve muscle mass as well.
    BioPharma Dive · 4mo ago↗ source
  • Rocket's PRV goes for $180M; Oruka targets $500M offering
    Rocket sells PRV for $180M: The New Jersey gene therapy maker sold the rare pediatric disease priority review voucher to an undisclosed buyer. Rocket Pharmaceuticals got the PRV after securing FDA ...
    Endpoints · 4mo ago↗ source
  • BeOne Medicines licenses trispecific antibody targeting PD-1, CTLA-4 and VEGF
    The pharma company formerly known as BeiGene has plucked an experimental cancer drug from a Chinese biotech, aiming to go broader than its competitors. BeOne Medicines said it signed a license and…
    Endpoints · 4mo ago↗ source
  • Incyte claims double Phase 3 win in vitiligo, will file for approval
    Incyte intends to seek approval of its JAK1 inhibitor pill in the skin disease nonsegmental vitiligo after the drug, povorcitinib, hit in twin Phase 3 trials. The company revealed the successes ...
    Endpoints · 4mo ago↗ source
  • FDA claims Amgen drug data were ‘manipulated’; Erasca slides despite ‘home run’ results
    Tavneos’ original developer hid a study analysis and then altered data, the FDA alleged. Elsewhere, Erasca’s RAS drug was met with skepticism and Rocket Pharma sold a voucher.
    BioPharma Dive · 4mo ago↗ source
  • Updated: AbbVie flirts with popular pan-RAS field in up to $1.45B option to acquire Kestrel
    The pan-RAS space continues to gain momentum, as AbbVie signs up for a shot at entering a field with the potential to drastically alter the treatment of certain cancers. The Chicago-area pharma gia…
    Endpoints · 4mo ago↗ source
  • FDA claims trial 'manipulation' tainted approval of ChemoCentryx drug
    The FDA accused ChemoCentryx of manipulating the results of a pivotal clinical trial used to approve the drug Tavneos, escalating the agency's effort to pull the treatment from the market. "New inf…
    Endpoints · 4mo ago↗ source