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  • Apnimed eyes up to $160M IPO to prep for sleep apnea drug launch
    If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.
    BioSpace · 1h ago↗ source
  • Oak Hill takes SPAC track to Nasdaq with Roche asset in tow
    Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.
    BioSpace · 1h ago↗ source
  • As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
    When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
    BioSpace · 7h ago↗ source
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  • MapLight dives despite positive data for schizophrenia drug
    <figure><div><img src="https://imgproxy.divecdn.com/hE3SUiWFPTXu78esitpkGlFwKNqX19ie92vbcO82d5g/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDQ5MjI0OTcwXzIua…
    BioPharma Dive · 20h ago↗ source
  • Argenx to acquire Forte in $2.2B deal for ‘differentiated’ immune drug
    <figure><div><img src="https://imgproxy.divecdn.com/nnTWCzHBd9_O2uNBVPF6xmxcO0M-nRFDpca5z-2Xchs/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDMwNzQzODA0LmpwZ…
    BioPharma Dive · 20h ago↗ source
  • UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy
    In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor's assertion that a Phase 3 trial met its primary outcome measures.
    BioSpace · 20h ago↗ source
  • MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout
    While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb's Cobenfy is likely to hold its market share.
    BioSpace · 20h ago↗ source
  • Gossamer regains rights to lung disease asset from Chiesi after Phase 3 fail
    Despite a Phase 3 miss, Gossamer Bio is full steam ahead for its lung disease asset, pointing to previous “review issues” at the FDA as one of the reasons to continue development.
    BioSpace · 20h ago↗ source
  • FDA scientists question Capricor data; Legend CEO steps down
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 21h ago↗ source
  • Sarepta names former AbbVie R&D exec Michael Severino as next CEO
    After leaving Tessera Therapeutics earlier this month, Michael Severino will take over Sarepta Therapeutics as the biotech awaits two key regulatory decisions in Duchenne muscular dystrophy.
    BioSpace · 21h ago↗ source
  • Sarepta, in search of a turnaround, taps ex-AbbVie exec Severino as CEO
    <figure><div><img src="https://imgproxy.divecdn.com/WuH_AaE1tfJ0k6kCbc3Pl9229iGeCCh2cRL_fgDY5lg/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9TYXJlcHRhX1Bob3RvXzEuSlBH.webp"/><…
    BioPharma Dive · 22h ago↗ source
  • AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure
    AstraZeneca remains "very much on track" to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said durin…
    BioSpace · 23h ago↗ source
  • Otsuka’s ADHD approval opens up new drug class with $615M opportunity
    Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
    BioSpace · 23h ago↗ source
  • Argenx deepens immuno expertise with $2.2B Forte Biosciences buy
    The star of the takeover is Forte Biosciences' investigational antibody therapy, FB102, which has shown early potential in vitiligo and celiac disease.
    BioSpace · 23h ago↗ source
  • [Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services
    <p>This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.</p>
    BioPharma Dive · 1d ago↗ source
  • [Podcast] (Season 2) The Progress Profile: Alzheimer’s Research in Focus
    <p>This podcast explores how leading Alzheimer’s experts are working to bridge the gap between clinical trial design and frontline care.</p>
    BioPharma Dive · 1d ago↗ source
  • From confidence to capital: Positioning biotech for the next growth cycle
    <p>How can biotechs be investor ready? Key takeaways from BIO International and DIA China 2026.</p>
    BioPharma Dive · 1d ago↗ source
  • Denmark’s foundation‑fueled biotech boom redraws the Nordic map
    Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.
    BioSpace · 1d ago↗ source
  • Lilly, AbbVie climb aboard in vivo CAR T train—but safety remains a hurdle
    Safety will be the key determinant of in vivo CAR T therapies, according to H.C. Wainwright’s Mitchel Kapoor, who noted that convenience and efficacy won’t be enough to impress investors in this sp…
    BioSpace · 1d ago↗ source
  • Summit, Merck must navigate new regulatory terrain in China-first cancer landscape
    Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be requir…
    BioSpace · 1d ago↗ source
  • FDA has recommitted to adcomms—but to what end?
    The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings…
    BioSpace · 1d ago↗ source
  • Recon: WHO releases first interim list of medical device authorities; AstraZeneca using AI to hedge late-stage risks
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 1d ago↗ source
  • Researchers find similar drug development to reimbursement timelines for major markets
    <p>Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.</p>
    raps · 1d ago↗ source
  • EMA says it takes ultimate responsibility for protecting online meeting registration, survey information
    <p>The European Medicines Agency (EMA) has issued notices stating how it will comply with certain stakeholder information protection under the Data Protection Regulation for EU institutions, bodies…
    raps · 1d ago↗ source
  • FDA finalizes three guidances to broaden cancer clinical trial eligibility
    <p>The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trial…
    raps · 1d ago↗ source