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294 stories matching this filter · ← front page

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  • Altimmune rises as GLP-1/glucagon drug curbs heavy drinking in mid-stage study
    Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics, among oth…
    BioSpace · 2d agoRegulatoryNeutral↗ source
  • 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 · 2d agoRegulatoryNeutral↗ source
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  • 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 · 2d agoRegulatoryNeutral↗ 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 · 3d agoApprovalPositive↗ 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 · 2d agoPositive readoutPositive↗ source
  • Lilly, AbbVie and others pursue in-vivo CAR-T, but safety concerns loom
    Analysts at H.C. Wainwright say safety will be the decisive factor for in‑vivo CAR‑T therapies, noting that convenience and efficacy alone will not win over investors. In‑vivo CAR‑T aims to genera…
    BioSpace · 3d agoNeutral↗ source
  • Summit Therapeutics reports positive Phase 3 data for lung cancer drug ivonescimab, highlighting regulatory hurdles for US approval
    Summit Therapeutics and its Chinese partner Akeso announced that their PD-1/VEGF antibody ivonescimab showed positive results in a Phase 3 trial for non-small cell lung cancer in Western patients.…
    BioSpace · 3d agoPositive readoutPositive↗ 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 · 3d agoDealNeutral↗ 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 · 3d agoDealNeutral↗ 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 · 2d agoRegulatoryNeutral↗ 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 · 2d agoRegulatoryNeutral↗ 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 · 2d agoRegulatoryNeutral↗ 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 · 3d agoRegulatoryNeutral↗ source
  • FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy
    The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate Matter
    July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consume…
    fda medwatch · 3d ago↗ source
  • Sanofi scraps most atopic dermatitis trials after amlitelimab fails to outperform standard care
    Sanofi announced it is halting all but one ongoing trial for amlitelimab, an OX40‑ligand antibody acquired through its $1.4 billion purchase of Kymab. The decision follows the Phase 3 COAST‑1 stud…
    BioSpace · 5d agoNegative readoutNegative↗ source
  • Scribe Therapeutics raises $129 million in rare early-stage IPO to fund epigenetic heart disease therapy
    Scribe Therapeutics, founded by Jennifer Doudna, completed an IPO raising nearly $129 million, selling 8.58 million shares at $15 each. It is the first gene‑editing company to go public in more tha…
    BioSpace · 5d agoDealPositive↗ source
  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 6d agoRegulatoryNegative↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 6d ago↗ source
  • Summit has less than a year of cash runway left as PD-1/VEGF verdict nears
    Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing…
    BioSpace · 6d ago↗ source
  • Roche cans one Carmot obesity asset as another shows best-in-class potential
    Acmopatide met the main goal of a Phase 2 study in type 1 diabetes, but Roche is axing the investigational drug to prioritize enicepatide for weight loss, type 2 diabetes and cardiovascular outcome…
    BioSpace · 6d ago↗ source
  • Early Alert: Percutaneous Catheter Issue from Boston Scientific
    ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use
    fda medwatch · 6d ago↗ source
  • Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate Matter
    July 24, 2026 - Taoyuan City, Taiwan - Sunny Pharmtech, Inc is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, to the User Level due to the presence of…
    fda medwatch · 6d ago↗ source
  • BAXTER ISSUES VOLUNTARY NATIONWIDE RECALL OF CEFAZOLIN IN DEXTROSE INJECTION, USP, 2G / 100ML (20MG / ML) SINGLE-DOSE INFUSION BAG IN 100ML DUE TO PARTICULATE MATTER FOUND IN SOLUTION
    July 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter…
    fda medwatch · 6d ago↗ source
  • Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbump
    An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
    BioSpace · 6d ago↗ source