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455 stories matching this filter · ← front page

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  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 13d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any…
    raps · 13d ago↗ source
  • FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
    The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasi…
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fda press · 14d ago↗ source
  • Celcuity gains FDA approval for closely watched breast cancer drug
    Still, shares fell by nearly 20% after the company revealed a delay in the coming launch of Revtorpyk. Details in the drug’s prescribing information surprised some analysts, too.
    BioPharma Dive · 14d ago↗ source
  • Merck ADC, in China study, shows potential to replace chemo in lung cancer
    The results were seen by Wall Street analysts as “direct proof-of-concept” that sac-TMT, a drug Merck views as a “cornerstone,” could be part of a future treatment standard for front-line lung cancer.
    BioPharma Dive · 14d ago↗ source
  • Braveheart, Attovia join next wave of biotech IPOs
    The two startups are the third and fourth, respectively, to outline offerings this month and aim to capitalize on momentum that’s already yielded several big-ticket IPOs.
    BioPharma Dive · 14d ago↗ source
  • J&J dips despite upbeat outlook; AstraZeneca, Spero cut China deals
    J&J’s shares ticked down as oncology sales missed expectations. Elsewhere, AstraZeneca bet $600 million on a lung cancer drug and a pair of biotechs snagged two of the year’s top venture rounds.
    BioPharma Dive · 14d ago↗ source
  • Diamantas backtracks on Makary’s policies issued in journal articles
    The acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official ag…
    raps · 14d ago↗ source
  • CVS Caremark reaches settlement with FTC over insulin suit
    Terms of the deal announced Tuesday are very similar to those the FTC reached with Express Scripts earlier this year, including requiring the PBM to stop preferring higher cost versions of drugs on…
    BioPharma Dive · 15d ago↗ source
  • Judge orders Apple Tree partner to forfeit oversight of venture fund
    The ruling from a Cayman Islands court adds a new wrinkle to an ongoing legal dispute that’s already resulted in a bankruptcy filing — and a bid by general partner Seth Harrison for the firm’s port…
    BioPharma Dive · 15d ago↗ source
  • Fresh off buyout, Akero execs reunite to advance long-acting psoriasis pill
    Set to go public via a reverse merger, Avere has licensed from a prolific Chinese drugmaker rights to a potential threat to medicines like Skyrizi and Icotyde.
    BioPharma Dive · 15d ago↗ source
  • Draig bags another $65M to speed testing of brain drugs
    The cash will support mid-stage trials of a prospect the company claims to have “best-in-disease” potential treating major depressive disorder.
    BioPharma Dive · 15d ago↗ source
  • Biogen data highlight promise, questions surrounding tau-targeting Alzheimer’s drugs
    The study provides the clearest evidence yet that medicines like BIIB080 might improve cognition, but leaves unclear why higher doses didn’t perform better.
    BioPharma Dive · 15d ago↗ source
  • Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VI
    Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry…
    raps · 15d ago↗ source
  • Freenome colorectal cancer test data improve on earlier results
    The new study results could make Abbott, which has an agreement with Freenome to market the blood-based test, the dominant player in colorectal cancer screening, Evercore ISI analysts said.
    BioPharma Dive · 16d ago↗ source
  • Q32 bounces back to claim study success for alopecia drug
    Nearly two years after clinical setbacks cratered Q32’s stock price, new results showed hair growth improvements that surpassed investors’ expectations.
    BioPharma Dive · 16d ago↗ source
  • Agenus surges on study pivot; Apnimed lines up an IPO
    Agenus is financially abandoning an ongoing study in late-line colorectal cancer. Elsewhere, an ebola vaccine began human testing and an important Bristol Myers medicine got an FDA decision date.
    BioPharma Dive · 16d ago↗ source
  • Biotech startup funding gap widens despite rebound in VC investment
    Though funding totals represented the highest first-half sum since the start of 2022, industry watchers are concerned that small startups are being left behind.
    BioPharma Dive · 16d ago↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 19d ago↗ source
  • FDA Proposes Rule to Modernize Drug Manufacturing Registration
    The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a…
    fda press · 19d ago↗ source
  • ARPA-H puts $160M into bespoke drug therapies; Biohaven switches up scientific leadership
    The ARPA-H program could provide researchers with a roadmap to develop personalized gene editing drugs. Elsewhere, a Botox rival succeeded against migraines and two deals were struck.
    BioPharma Dive · 19d ago↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 20d ago↗ source
  • GSK ends brain drug alliance with Alector
    Clinical setbacks derailed what was once a potentially $2.2 billion deal that marked GSK's return to neuroscience.
    BioPharma Dive · 20d ago↗ source
  • HHS plan to speed drug research won’t remove ‘self-inflicted’ delays
    U.S. clinical trials continue to lose ground to China, but is Operation Trialblazer enough to help America catch up?
    BioPharma Dive · 20d ago↗ source
  • AstraZeneca, Ionis drug fails big heart disease study in major setback
    Eplontersen’s failure in transthyretin-mediated amyloidosis cardiomyopathy caught Wall Street analysts by surprise and boosted the outlook of rival drugs from Alnylam and BridgeBio Pharma.
    BioPharma Dive · 20d ago↗ source