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  • FDA moves to speed trials by reviewing AstraZeneca and Amgen data in real time, seeks public input on pilot program
    The U.S. Food and Drug Administration announced a new initiative aimed at making clinical trials faster and more efficient. As a first step, the agency will begin reviewing trial data in real time…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Health Secretary Kennedy moves to reverse FDA ban on peptide compounding, raising safety concerns
    Health Secretary Robert F. Kennedy Jr. is pushing to overturn a 2023 FDA rule that stopped compounding of certain peptides, a move that could reopen a market for products such as BPC-157 and GHK-Cu…
    STAT · 4mo agoRegulatoryNegative↗ source
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  • FDA reports most U.S. infant formulas contain only trace or undetectable levels of heavy metals and other contaminants
    The Food and Drug Administration examined 312 samples drawn from 16 major infant‑formula brands, looking for residues of heavy metals, pesticides, PFAS and phthalates. Across the board the agency…
    STAT · 4mo agoRegulatoryPositive↗ 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
  • Medical students debate how to improve nutrition and preventive health training in med schools
    The article is an opinion piece that examines medical students' views on Health Secretary Robert F. Kennedy's call for stronger nutrition and preventive medicine education in medical school. It fe…
    STAT · 4mo agoNeutral↗ source
  • Report shows modest health equity gains but experts warn they may not last
    A new Commonwealth Fund report covering 2022 to 2024 highlights several state-level actions that narrowed health disparities. Two states broadened Medicaid eligibility, many expanded postpartum cov…
    STAT · 4mo agoNegative↗ source
  • Federal autism advisory committee meets for first time in 19 months, targets support for profound autism
    The Interagency Autism Coordinating Committee held its first session in 19 months, convening after Health Secretary Robert F. Kennedy Jr. removed most of the panel’s scientific experts and appointe…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Food safety experts warn of talent loss at USDA amid broader health policy updates
    Food safety experts cautioned that the USDA is experiencing a significant loss of scientific talent, which could affect its ability to oversee food safety programs. The autism advisory committee,…
    STAT · 4mo agoNeutral↗ source
  • Alternative medicine often feels more personal than conventional care, says physician
    Dr. Hannah Kerman, a New York physician, writes that many patients turn to acupuncturists or massage therapists because they feel more attended to than during typical medical visits. She describes…
    STAT · 4mo agoNeutral↗ 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
  • Eli Lilly partners with AI startup Profluent to develop next-generation gene editors
    Eli Lilly announced a collaboration with AI-focused biotech Profluent to create advanced gene-editing tools that could insert whole genes into patients. The partnership is intended to move beyond…
    STAT · 4mo agoDealPositive↗ 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
  • Novartis CEO says Trump’s drug pricing plan creates a very difficult situation for makers and patients
    Novartis chief executive Vas Narasimhan warned that the United States drug‑pricing policy under President Trump presents a "very difficult situation" for both drugmakers and patients. He said the…
    STAT · 4mo agoRegulatoryNegative↗ 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
  • AIDS advocacy group sues Trump administration over hidden Gilead HIV-prevention settlement
    The AIDS advocacy group PrEP4All filed a lawsuit against the Trump administration, alleging it failed to disclose a research and development agreement with Gilead Sciences. The agreement was part…
    STAT · 4mo agoRegulatoryNegative↗ source
  • FDA launches AI-driven pilot to review trial data in real time, aiming to speed clinical studies
    Washington officials said the Food and Drug Administration is starting a new program to speed clinical trials by reviewing data as it is generated. The first pilots will use real-time data from tr…
    STAT · 4mo agoRegulatoryPositive↗ 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
  • FDA commissioner touts real-time trial monitoring to cut drug development dead time
    The Food and Drug Administration announced a new approach that will let regulators view clinical trial endpoints as they happen, using cloud‑based data streams. The move targets the long delays th…
    STAT · 4mo agoRegulatoryPositive↗ source