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  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 6h agoApprovalPositive↗ source
  • FTC sues Hims & Hers over alleged health data sharing and deceptive billing practices
    The Federal Trade Commission filed a lawsuit against Hims & Hers, a telehealth company based in San Francisco, accusing it of improper handling of patient information. According to the complaint,…
    Endpoints · 3h agoRegulatoryNegative↗ source
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  • US releases $600M pledged to global vaccine alliance Gavi after year‑long delay
    The United States has released the $600 million it pledged to Gavi, the global vaccine alliance. The funds had been held in limbo for about a year before the Treasury completed the transfer. Sena…
    Endpoints · 3h agoDealPositive↗ source
  • FDA and Capricor clash over Duchenne cell therapy efficacy at advisory committee
    At an FDA advisory committee meeting, the agency and Capricor Therapeutics presented conflicting views on the efficacy data for the company's experimental cell therapy aimed at Duchenne muscular dy…
    Endpoints · 4h agoRegulatoryNegative↗ source
  • Atea's hepatitis C combo therapy shows non-inferior results to Gilead's Epclusa
    Atea Pharmaceuticals announced that its oral combination of bemnifosbuvir and ruzasvir met the predefined non-inferiority criteria when compared with Gilead's Epclusa for treating hepatitis C. The…
    Endpoints · 7h agoPositive readoutPositive↗ source
  • Leqembi posts $184M Q2 sales, best quarter since launch, Biogen lifts guidance
    Leqembi, the anti-amyloid Alzheimer’s drug co-developed by Eisai and Biogen, generated $184 million in global sales in the second quarter, according to Biogen. The Q2 figure represents the stronge…
    Endpoints · 13h agoEarningsPositive↗ source
  • Teva says it has time to prepare for upcoming US tariffs on imported generic drugs
    Teva CEO Richard Francis said the company believes it has sufficient time to prepare for the tariffs the Trump administration is considering on generic drugs imported from outside the United States…
    Endpoints · 5h agoRegulatoryNeutral↗ source
  • AI startup Doctronic acquires text-message pediatric care provider Summer Health
    Doctronic, a startup that markets itself as an AI doctor, announced it has purchased Summer Health, a company that offers pediatric care via text messaging. The acquisition expands Doctronic’s ser…
    Endpoints · 11h agoDealNeutral↗ source
  • Former Recursion CEO Chris Gibson joins Dimension Capital as operating partner
    Chris Gibson, who led Recursion Pharmaceuticals for a decade, has taken a new role at venture firm Dimension Capital. At Dimension, he will serve as an operating partner, bringing his experience a…
    Endpoints · 12h agoPositive↗ source
  • NYU's Neil Vasan steps down as acting chair of FDA's oncology drug advisory committee
    Neil Vasan, a professor at NYU, has announced he is stepping down from his role as acting chair of the FDA’s Oncologic Drugs Advisory Committee (ODAC). Vasan has participated in 22 ODAC meetings a…
    Endpoints · 6h agoRegulatoryNeutral↗ source
  • Two biotechs sign reverse mergers to advance I&I drug, BTK inhibitor
    A biotech with a bispecific antibody from China and a little-known San Diego startup with a BTK inhibitor from Gossamer Bio have each signed reverse mergers to take their experimental medicines ont…
    Endpoints · 8h ago↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA reminds investors about the risks of advisory panels
    Two days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from both Capricor Therapeutics and
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • FDA offers updated guidance for generics of weight loss blockbusters
    The FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's Ozempic…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • FDA staff say Replimune's melanoma trial failed to prove RP1 works
    FDA staff threw cold water on Replimune’s advanced melanoma drug ahead of a critical meeting with agency advisors, writing that the pivotal study design failed to prove its drug actually works. The…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • The future of gray-market peptides
    Two days’ worth of debate among FDA advisory committee members and agency staff over whether compounding pharmacies should be able to make seven different peptides left me with some big ...
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
    The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
    raps · 1d agoRegulatoryNeutral↗ source
  • J&J proposes $5.5B talc settlement
    After more than a decade and three failed bankruptcy attempts, an end to Johnson & Johnson’s talc saga may finally be in sight. The company has proposed a $5.5 billion settlement ...
    Endpoints · 1d agoNeutral↗ source
  • Oak Hill Bio merges with RA Capital SPAC; InnoCare's TYK2 drug hits in Phase 3
    💵 Oak Hill Bio’s SPAC merger: The Angelman syndrome biotech will merge with RA Capital’s blank-check company, called Research Alliance Corporation III, and get about ...
    Endpoints · 1d agoNeutral↗ source
  • Alnylam's stock is down 30% despite a booming biotech market. Here's why
    Alnylam is one of biopharma’s biggest mysteries so far in 2026. The broader market is seeing a resurgence after years of a bearish environment. M&A is up, IPOs are back with record-breaking force a…
    Endpoints · 1d agoNeutral↗ source
  • Mirae raises $5.4M to turn patient texts into data for doctors
    As people increasingly turn to AI chatbots for health questions, one startup wants patients to talk to its chatbot about their symptoms, so their doctors can make better treatment decisions. Mirae,…
    Endpoints · 1d agoNeutral↗ source
  • Claris collects $118M to take eye drop into pivotal testing next year
    Claris Bio has a fresh CEO, new board chair and $118 million for two pivotal trials to see if its eye drop can succeed in a blinding disease with no pharmaceutical treatment options. It's a ...
    Endpoints · 1d agoNeutral↗ source
  • Updated: GSK reveals three-year blueprint to cut costs and propel R&D
    Just a little over six months into his tenure as CEO at GSK, Luke Miels is making his mark. The drugmaker on Tuesday outlined plans for a three-year cost-cutting initiative, the launch of at least ...
    Endpoints · 1d agoNeutral↗ source
  • Updated: Altimmune’s GLP-1-based shot cuts drinking in patients with alcoholism
    Altimmune said Tuesday that its GLP-1/glucagon agonist reduced drinking in people with moderate-to-severe alcohol use disorder in a mid-stage study. Patients in the Phase 2 RECLAIM trial took a wee…
    Endpoints · 1d agoNeutral↗ source