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  • 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 · 2mo agoDealPositive↗ source
  • 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 · 2mo agoRegulatoryNeutral↗ source
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  • 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 · 2mo agoRegulatoryNegative↗ 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 · 2mo 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 · 2mo agoEarningsNeutral↗ 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 · 2mo 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 · 2mo agoCRLNegative↗ 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 · 2mo agoDealPositive↗ 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 · 2mo agoCRLNegative↗ source
  • Gilead reports modest sales rise but analysts question future growth beyond HIV drugs
    Gilead's second‑quarter results showed total product revenue of $7.6 billion, up 8% year‑over‑year. The company's two leading HIV treatments, Biktarvy and Descovy, together generated about $5.7 bi…
    BioPharma Dive · 2mo agoEarningsNeutral↗ source
  • Sun Noodle voluntarily recalls 134 packages of Sura Tanmen hot and sour noodles in Hawaii over undeclared fish allergen
    Sun Noodle of Honolulu announced a voluntary recall of its Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. The recall covers 134 packages, each 15.4 ounces, identified by lot…
    fda recalls · 2mo agoCRLNegative↗ source
  • Vertex posts strong Q2 earnings, but upcoming Sionna cystic fibrosis data casts a shadow
    Vertex reported Q2 revenue from its cystic fibrosis portfolio exceeding $3.2 billion, beating estimates and prompting an upward revision of full‑year revenue guidance to $13.1‑$13.2 billion. Analy…
    BioPharma Dive · 2mo agoEarningsNeutral↗ source
  • J&J pharma chief Jennifer Taubert to retire; Krystal Biotech shares plunge after gene therapy revenue shortfall
    Johnson & Johnson announced that Jennifer Taubert will step down as head of its pharmaceutical division after a 21‑year tenure. During her time she oversaw commercial strategy, dealmaking and the…
    BioPharma Dive · 2mo agoNegative↗ source
  • Pfizer expands cost-cutting program, targeting $1 billion in new savings through 2029
    Pfizer announced it is expanding a cost-cutting initiative first launched in 2023 to further reduce expenses. The new measures are projected to generate about $1 billion in additional savings by 2…
    BioPharma Dive · 2mo agoNeutral↗ source
  • Early Alert: Intraosseous Needle Set Issue from Becton Dickinson
    BD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.
    fda medwatch · 2mo agoRegulatoryNeutral↗ source
  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA invites stakeholder input to shape a new Quantitative Medicine Innovation Network
    The FDA announced it is looking for feedback from a broad range of stakeholders to help design a Quantitative Medicine Innovation Network (QMIN). The proposed QMIN would be a cross-sector platform…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Liebel-Flarsheim recalls OPTIRAY imaging contrast agent after detecting plastic, metal and glass particles
    Liebel-Flarsheim Company announced a recall of one lot of its OPTIRAY Imaging Bulk Package, a 350/500 mL vial of ioversol injection used for intra‑arterial and intravenous imaging. The recall was…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Experts debate extra regulation for low-risk digital wellness devices
    Two recent papers published in JAMA have highlighted concerns about low-risk digital health technologies that consumers use. Experts say that even though these tools are considered low-risk, they…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Blank Slate Creamery recalls vegan coconut fudge sandwiches over undeclared egg allergen
    Blank Slate Creamery of Ann Arbor, Michigan announced a recall of its 4.5‑ounce vegan non‑dairy frozen dessert coconut fudge sandwiches because the product may contain egg, an undeclared allergen.…
    fda recalls · 2mo agoCRLNegative↗ source
  • Wall Street reacts negatively to AstraZeneca-Bristol Myers merger talks, shares tumble
    A report in the Financial Times, followed by Reuters, said AstraZeneca and Bristol Myers Squibb have been discussing a possible combination in recent months. The news triggered a sharp sell-off. A…
    BioPharma Dive · 2mo agoDealNegative↗ source
  • BioNTech appoints Sobi head Guido Oelkers as new CEO to steer oncology shift
    BioNTech announced that Guido Oelkers, who has led the rare‑disease focused Swedish company Sobi since 2017, will become its next chief executive officer. Oelkers is slated to take over the role b…
    BioPharma Dive · 2mo agoNeutral↗ source
  • Supernus and Individor to merge, creating $2 billion brain-drug company
    Supernus and Individor announced a merger that will combine their portfolios of neurological medicines. The two firms together generated about $2 billion in revenue in 2025 from roughly a dozen CN…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • BD recalls specific lots of intraosseous needle sets over obturator removal issues
    BD announced a voluntary recall of certain lots of its intraosseous vascular access system needle sets after users reported difficulty removing the obturator after placement. The issue is linked t…
    fda medwatch · 2mo agoCRLNegative↗ source
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 2mo agoRegulatoryNeutral↗ source