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47 stories matching this filter · ← front page

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STAT1056Endpoints798BioPharma Dive306BioSpace231Fierce Biotech218onclive165raps82globenewswire health
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allOncology6231Rare Disease1510Cardiology1126Hematology1063Immunology1048Vaccines939Pulmonology
  • Haisco partners with US VCs to launch immunology biotech Sentivera with up to $1.5B funding
    Haisco Pharmaceutical Group announced the creation of a new immunology-focused biotech called Sentivera, backed by two American venture‑capital firms, Population Health Partners and ARCH Venture Pa…
    BioSpace · 2h agoDealPositive↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 2h agoLayoffsNegative↗ source
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fda medwatch49
fda recalls48
fda press28
923
Psychiatry & CNS745
Ophthalmology451
Pain418
Endocrinology & Metabolism395
Infectious Disease374
  • Vitruvias Therapeutics recalls one lot of 30 mg thyroid tablets over super potency risk
    Vitruvias Therapeutics announced a voluntary recall of a single lot (Lot No. 504950) of its 30 mg thyroid tablets to the consumer level. Testing confirmed the tablets could be superpotent, raising…
    fda medwatch · 1d agoCRLNegative↗ source
  • Werewolf Therapeutics merges with Ambros in $150M deal to advance non‑opioid painkiller for rare limb injury syndrome
    Werewolf Therapeutics and Ambros Therapeutics announced a merger valued at $150 million, creating a new company that will retain the Ambros name. The deal includes a private placement to fund the…
    BioSpace · 4d agoDealPositive↗ source
  • Ambros Therapeutics merges with Werewolf, raises $150M to fund phase 3 trial of rare disease drug
    Ambros Therapeutics announced an all‑stock reverse merger with Werewolf Therapeutics, accompanied by a $150 million private placement. The transaction will see the combined company operate under th…
    Fierce Biotech · 4d agoDealPositive↗ source
  • FDA issues early alert on Medical Action epidural kits containing recalled sodium chloride ampules
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert warning about certain epidural kits from Medical Action Industries. The alert notes that the kits include sodium chlor…
    fda medwatch · 4d agoRegulatoryNegative↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 5d agoApprovalPositive↗ source
  • Medline recalls convenience kits with B. Braun bupivacaine component, urges correction before use
    Medline has issued a correction for a range of its convenience surgical kits after discovering that they contain components from B. Braun Medical that include bupivacaine hydrochloride in a dextros…
    fda medwatch · 5d agoCRLNegative↗ source
  • Optimal Balance Pharmacy recalls one lot of compounded glutathione injection over high endotoxin levels
    Optimal Balance Pharmacy announced a voluntary recall of a single lot of its compounded glutathione 200 mg/mL multi‑dose vials. The recall was triggered after internal testing detected elevated bac…
    fda medwatch · 5d agoCRLNegative↗ source
  • Heidi Overton nominated as FDA commissioner, seen as boost for psychedelics and non-opioid pain drugs
    President Donald Trump announced that he will nominate Heidi Overton, a current White House policy advisor, to serve as the next FDA commissioner pending Senate confirmation. Analysts say Overton’…
    BioSpace · 5d agoRegulatoryNeutral↗ source
  • Biopharma hiring surges in New Jersey, 11 companies post dozens of new roles
    BioSpace data shows job postings for biopharma positions in New Jersey have risen year over year, with a notable 73% jump in July compared with the same month last year. The upward trend has persi…
    BioSpace · 6d agoPositive↗ source
  • LEO Pharma spends $435 million to acquire rare-disease skin drug dersimelagon
    LEO Pharma announced it will pay $435 million to buy the rights to dersimelagon, an oral MC1R agonist originally developed by Tanabe Pharma. The drug has completed Phase 3 trials for two rare phot…
    BioSpace · 7d agoDealPositive↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial after safety concerns
    Regeneron announced termination of a Phase 1/2 study of its investigational anti-inflammatory antibody REGN7041, which was being evaluated for non-infectious uveitis. The company said the decision…
    BioSpace · 7d agoNegative↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial over unfavorable risk-benefit profile
    Regeneron has stopped a Phase 1/2 study of its anti‑inflammatory antibody REGN7041 in non‑infectious uveitis, citing an unfavorable benefit‑risk assessment. The antibody targets CD3 on immune cell…
    BioSpace · 7d agoNegative readoutNegative↗ source
  • Leo Pharma signs $435 million deal with Tanabe for rare skin disease drug dersimelagon
    Leo Pharma announced a licensing agreement with Mitsubishi Tanabe Pharma for worldwide rights to dersimelagon, an oral melanocortin-1 receptor agonist targeting rare genetic skin disorders. The dr…
    Fierce Biotech · 8d agoDealPositive↗ source
  • Eli Lilly signs up to $370M ion-channel collaboration with OmniAb
    Eli Lilly has entered a collaboration with antibody platform company OmniAb that could involve up to $370 million in research, development and commercial milestone payments. OmniAb, which was spun…
    Fierce Biotech · 8d agoDealPositive↗ source
  • Bankrupt Sangamo sells Fabry gene therapy to PTC and prion program to Lilly for $161M
    Sangamo Therapeutics, currently in Chapter 11 bankruptcy, has agreed to divest its Fabry disease gene therapy and several other platforms to raise cash for the restructuring. PTC Therapeutics emer…
    BioSpace · 12d agoDealNeutral↗ source
  • Medline issues correction for convenience kits containing recalled ICU Medical pain management components
    Medline announced a correction for certain convenience kits that include ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection. The FDA classified…
    fda medwatch · 13d agoCRLNegative↗ source
  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda medwatch · 14d agoCRLNegative↗ source
  • MoonLake reports all endpoints met in phase 3 trial of sonelokimab for psoriatic arthritis
    MoonLake Immunotherapeutics said its lead nanobody sonelokimab achieved positive topline results in a phase 3 study of patients with psoriatic arthritis. At week 16, 42.1% of participants reached…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 15d agoDealNeutral↗ source
  • BlossomHill and Latigo Biotherapeutics raise over 30% beyond IPO targets
    Two emerging biotech companies surpassed their initial public offering expectations on Friday, with both BlossomHill Therapeutics and Latigo Biotherapeutics raising at least 30% more capital than p…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Braveheart Bio targets $382 million IPO to fund cardiac drug development
    Braveheart Bio announced an upsized initial public offering on the Nasdaq, aiming to raise about $382.5 million. The company will sell 21.2 million shares at $18 each under the ticker BRVE. The pr…
    BioSpace · 19d agoDealPositive↗ source
  • Eli Lilly posts $23 B Q2 revenue, beats forecasts as Foundayo lags behind Novo's oral GLP-1
    Eli Lilly reported second‑quarter revenue of $23 billion, a 48% increase from the prior year and well above analysts' expectations. The strong top‑line helped the company deliver a sizable earnings…
    BioSpace · 20d agoEarningsNeutral↗ source
  • Lilly and FDA clash over retatrutide classification as company nears submission
    Eli Lilly is preparing to file its obesity drug candidate retatrutide for approval while a legal dispute with the FDA over the drug's classification intensifies. The agency has concluded that reta…
    BioSpace · 19d agoRegulatoryNeutral↗ source