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579 stories matching this filter · ← front page

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  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 25d agoRegulatoryNeutral↗ source
  • MapLight’s schizophrenia pill hits primary endpoint but falls short of challenging BMS’s Cobenfy
    MapLight Therapeutics reported results from its Phase 2 ZEPHYR trial of the oral muscarinic agonist ML-007C-MA in schizophrenia. The trial met its primary endpoint, showing a statistically signifi…
    BioSpace · 25d agoPositive readoutNeutral↗ source
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  • Gossamer Bio regains rights to lung disease asset from Chiesi after Phase 3 failure, eyes FDA submission
    Gossamer Bio announced that it has taken back the rights to its inhaled pulmonary hypertension candidate from partner Chiesi after the drug failed to meet its primary endpoint in a Phase 3 trial.…
    BioSpace · 25d agoNegative readoutNeutral↗ source
  • Study shows drug development and reimbursement timelines align across four major markets
    Researchers published a cross‑sectional analysis in JAMA Health Forum examining how long it takes for a drug to move from the start of clinical trials to receiving reimbursement approval. The anal…
    raps · 25d agoNeutral↗ source
  • AstraZeneca says Wainua failure won’t alter M&A plans, stays on track for $80B 2030 goal
    AstraZeneca said during its Q2 earnings presentation that the late‑stage failure of the antisense therapy Wainua in ATTR‑cardiomyopathy does not derail its goal of reaching $80 billion in revenue b…
    BioSpace · 25d agoDealNeutral↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 25d agoRegulatoryNeutral↗ source
  • Nokia executive Pallavi Mahajan purchases 62,000 shares at $9.55 each
    Nokia reported an insider transaction by Pallavi Mahajan, a member of the senior management team. The filing indicates Mahajan bought 62,000 Nokia shares on July 24, 2026, at a price of $9.55 per…
    globenewswire health · 25d agoDealNeutral↗ 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 · 25d agoRegulatoryNeutral↗ source
  • Vaisala executive Vesa Pylvänäinen sells 1,582 shares at €56.92 each
    Vaisala Oyj disclosed a transaction by senior executive Vesa Pylvänäinen on July 23, 2026. He disposed of 1,582 ordinary shares of the company on the Nasdaq Helsinki market at an average price of…
    globenewswire health · 25d agoNeutral↗ source
  • Vaisala senior manager Vesa Pylvänäinen disposes 1,582 shares at €56.92 each
    Vaisala Corporation disclosed that senior manager Vesa Pylvänäinen sold a portion of his holdings. The disposal involved 1,582 shares of Vaisala A shares, with a volume‑weighted average price of €…
    globenewswire health · 25d agoNeutral↗ source
  • Nokia senior manager Pallavi Mahajan buys 62,000 shares at $9.55 each
    Nokia disclosed that senior manager Pallavi Mahajan filed a transaction notice under the EU Market Abuse Regulation. The notice, dated July 24, 2026, records Mahajan's purchase of 62,000 Nokia sha…
    globenewswire health · 25d agoRegulatoryNeutral↗ source
  • Nokia senior manager Patrik Hammarén acquires 43,293 shares at €8.44 each
    Nokia Corporation disclosed that senior manager Patrik Hammarén purchased shares of the company. The acquisition was made on July 24, 2026 and involved a total of 43,293 shares at a unit price of…
    globenewswire health · 25d agoRegulatoryNeutral↗ source
  • Nokia board member Timo Ihamuotila reports share purchases across multiple markets on July 24, 2026
    Nokia Oyj disclosed an insider transaction by board member Timo Ihamuotila, filed under the market abuse regulation article 19 as an initial notification. The first purchase was made on the BEUP m…
    globenewswire health · 25d agoNeutral↗ source
  • Nokia board member Timo Ihamuotila purchases 33,700 shares at around €8.45 each
    On July 24, 2026, Timo Ihamuotila, a member of Nokia Corporation's board, executed multiple share purchases. He acquired 24,340 shares on the BEUP venue at a price of €8.4449 per share. Additiona…
    globenewswire health · 25d agoNeutral↗ source
  • Nokia executive Patrik Hammarén reports share purchase of 43,293 shares at €8.44 each
    Nokia Oyj disclosed a leadership transaction filed under market abuse regulation article 19. The filing lists senior executive Patrik Hammarén as the reporting person. The transaction involved a t…
    globenewswire health · 25d agoDealNeutral↗ source
  • Danske Bank reports share sales by APMH Invest under its buyback program
    On July 27, 2026, Danske Bank A/S filed a market-abuse regulation report detailing changes in share ownership. The filing shows that APMH Invest A/S sold shares of Danske Bank on a pro-rata basis…
    globenewswire health · 25d agoRegulatoryNeutral↗ source
  • Danske Bank reports ongoing share sales by APMH Invest under its buy-back program
    Danske Bank A/S filed a notification on 27 July 2026 regarding transactions made by persons required to report under the EU Market Abuse Regulation. The bank’s share buy-back program continues, an…
    globenewswire health · 25d agoRegulatoryNeutral↗ 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 · 28d 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 · 28d 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 · 28d agoRegulatoryNegative↗ source
  • Summit Therapeutics faces under a year of cash runway as FDA decision on ivonescimab looms
    Summit Therapeutics reported that its cash and short-term investments total just over $690 million, which the company says is insufficient to fund operations for a full year. The biotech’s lead ca…
    BioSpace · 28d agoRegulatoryNeutral↗ source
  • Roche drops Carmot’s acmopatide after Phase 2 success, shifts focus to enicepatide for weight loss and diabetes
    Roche announced it will stop developing acmopatide, an investigational obesity treatment acquired from Carmot Therapeutics. Acmopatide had met its primary endpoint in a Phase 2 trial in type 1 dia…
    BioSpace · 28d agoNeutral↗ source
  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 28d agoCRLNegative↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 28d agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 28d agoRegulatoryNeutral↗ source