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  • Braveheart Bio raises $382.5M in IPO to fund phase 3 trial of cardiac drug
    Braveheart Bio, a San Francisco biotech, completed an IPO that raised $382.5 million, exceeding its original target. The company increased the share count to 21.2 million and set the price at $18…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Cardiac biotech Braveheart raises $382.5M in IPO, launches on Nasdaq as BRVE
    Braveheart Bio, a cardiac drug developer, priced its initial public offering on Wednesday and secured $382.5 million in proceeds. The company sold about 21.2 million shares at $18 each, exceeding t…
    BioPharma Dive · 19d agoDealPositive↗ source
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  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 19d agoRegulatoryNeutral↗ source
  • Medline recalls Hudson RCI neonatal heated wire breathing circuits over connector overheating risk
    Medline Industries announced a nationwide recall of its Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. The recall was triggered after the company received reports of sporadic failures i…
    fda medwatch · 19d agoRegulatoryNegative↗ source
  • Tiziana Life Sciences CEO Ivor Elrifi buys 321,423 shares, raising his stake to 4.79 million
    Tiziana Life Sciences announced that its chief executive, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The transaction brings Elrifi’s total ownership…
    globenewswire health · 19d agoDealPositive↗ source
  • Novo Nordisk reports board and executive share transactions under EU market abuse rules
    On August 6, 2026 Novo Nordisk issued a company announcement detailing share transactions made by members of its board, senior executives and their close associates in line with Article 19 of EU Re…
    globenewswire health · 19d agoRegulatoryNeutral↗ source
  • Context Therapeutics drops CT-95 bispecific T-cell engager to stretch cash runway to 2027
    Context Therapeutics announced it is halting development of its bispecific T-cell engager CT-95. The company acquired CT-95 in 2024 for $3.7 million and began dosing patients in a phase 1 trial in…
    Fierce Biotech · 19d agoNegative↗ source
  • Actimed regains full rights to S-oxprenolol, ends $126 million Faraday licensing deal
    Actimed Therapeutics announced it has reclaimed all worldwide rights to its experimental wasting disease drug S-oxprenolol, terminating the licensing agreement it had with Faraday Pharmaceuticals.…
    Fierce Biotech · 19d agoDealNeutral↗ source
  • Tiziana Life Sciences CEO Ivor Elrifi boosts stake, buying 321,423 shares at $1 each
    Tiziana Life Sciences announced that its chief executive officer, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The purchase raises his total holding to…
    globenewswire health · 19d agoDealPositive↗ source
  • Vistagen's anxiety nasal spray fails to outperform placebo in phase 2 trial
    Vistagen Therapeutics reported that its experimental nasal spray fasedienol did not show a statistically significant advantage over placebo in a phase 2 study of social anxiety disorder. The trial…
    Fierce Biotech · 19d agoNegative readoutNegative↗ source
  • PacBio appoints COO Mark Van Oene as new CEO after Christian Henry steps down
    PacBio announced that its chief operating officer, Mark Van Oene, will become president and chief executive officer effective Aug. 5 and will join the company's board. Van Oene, who joined PacBio…
    Fierce Biotech · 19d agoNeutral↗ source
  • EMA launches consultation to streamline nonclinical development for life-threatening diseases
    EMA announced a public consultation on proposals to accelerate the nonclinical phase of drug development for diseases that are severely debilitating or life‑threatening. The agency aims to reduce…
    raps · 19d agoRegulatoryNeutral↗ source
  • Novo Nordisk board members disclose share vesting transactions
    Novo Nordisk issued a regulatory announcement on 6 August 2026 detailing share transactions by its board members, executives and related persons, as required by EU market abuse regulation. The fil…
    globenewswire health · 19d agoRegulatoryNeutral↗ source
  • InstallatørGruppen reports insider share transaction involving board members' associate
    InstallatørGruppen A/S has filed a Market Abuse Regulation (EU) No. 596/2014 notification under article 19, disclosing a recent share transaction. The transaction was executed by Absalon Holdings…
    globenewswire health · 19d agoRegulatoryNeutral↗ source
  • InstallatørGruppen reports share transaction by board linked entity Absalon Holdings
    InstallatørGruppen A/S filed a notification under the EU Market Abuse Regulation, article 19, to disclose a share transaction involving a person discharging managerial responsibilities and their cl…
    globenewswire health · 19d agoRegulatoryNeutral↗ source
  • Lilly beats forecasts while Novo Nordisk misses sales and trial targets
    Eli Lilly reported second-quarter revenue of nearly $23 billion, up 48% year-over-year, easily surpassing analysts’ $20.6 billion estimate. The boost came from continued strength of its tirzepatide…
    BioPharma Dive · 20d agoEarningsNeutral↗ source
  • Novo Nordisk reports mixed trial results for CagriSema and ziltivekimab, cites setbacks and seeks bolt-on deals
    Novo Nordisk's chief executive said the company has experienced "a couple of setbacks" after recent trial data. The phase 3 study of ziltivekimab, an IL‑6 ligand antibody, did not show a statistica…
    Fierce Biotech · 20d agoNegative readoutNegative↗ source
  • LifeMine Therapeutics secures $188 million Series E funding from Gates, Bezos and others
    LifeMine Therapeutics, a Massachusetts biotech, recently completed a $188 million Series E round, attracting billionaire investors Bill Gates and Jeff Bezos. The funding follows a $75 million Seri…
    Fierce Biotech · 20d agoDealPositive↗ source
  • Attovia Therapeutics raises $289 million in IPO to fund antibody-drug research for skin and inflammatory diseases
    Attovia Therapeutics completed an IPO raising $289 million, selling 17 million shares at $17 each and valuing the company at $767 million. Shares will begin trading on Nasdaq under the ticker ATTO.…
    BioPharma Dive · 20d agoDealPositive↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda medwatch · 20d agoCRLNegative↗ source
  • Emergent BioSolutions cuts 93 jobs and eliminates chief medical officer role in new restructuring plan
    Emergent BioSolutions announced a new round of restructuring aimed at aligning the company with current business realities, disclosed alongside its second‑quarter earnings. The plan includes layin…
    Fierce Biotech · 20d agoLayoffsNegative↗ source
  • Expedition Therapeutics secures $115M Series B to advance China-origin COPD drug
    Expedition Therapeutics, a biotech that licenses drugs from Chinese firms, announced a $115 million Series B financing that will fund mid-stage testing of its experimental COPD candidate. The fund…
    BioPharma Dive · 20d agoDealPositive↗ source
  • Fecal microbiome transplant boosts peanut tolerance sixfold in early trial
    Researchers at Boston Children’s Hospital conducted a small open‑label phase 1 trial in which 15 adult participants received oral encapsulated fecal microbiome transplantation to test safety and ef…
    Fierce Biotech · 20d agoPositive readoutPositive↗ source
  • Novo Nordisk CFO describes roller-coaster growth and stays optimistic about CagriSema after Q2 earnings
    Novo Nordisk CFO Karsten Munk Knudsen talked to Fierce after the company released its second-quarter earnings, reflecting on his nine-year tenure and the firm’s volatile performance. He recalled a…
    Fierce Biotech · 20d agoEarningsNeutral↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 20d agoCRLNegative↗ source