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22 stories matching this filter · ← front page

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STAT834Endpoints639BioPharma Dive243onclive165BioSpace97Fierce Biotech96raps37globenewswire health
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allOncology5001Rare Disease846Cardiology797Hematology768Immunology729Psychiatry & CNS582Pulmonology
  • Moderna maintains 10% growth target despite Phase 3 norovirus miss
    Moderna’s norovirus vaccine failed in a Phase 3 trial, but the company still has faith in an ambitious revenue growth target thanks to ex-U.S. vaccine sales and a unanimous FDA adcomm win for mFLUS…
    BioSpace · 3h ago↗ source
  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 1d agoDealPositive↗ source
28
fda recalls22
fda press21
fda medwatch17
570
Vaccines516
Endocrinology & Metabolism290
Ophthalmology255
Infectious Disease253
Nephrology238
Biotech earnings season kicks off as Agios reports Phase 2 setback for sickle-cell drug
The second‑quarter earnings window has begun, and analysts are zeroing in on a handful of biotech companies with high‑profile catalysts. Smaller biotechs are increasingly opting to launch their pr…
BioSpace · 2d agoNegative readoutNeutral↗ 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 · 2d agoLayoffsNegative↗ source
  • 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 · 3d agoRegulatoryNeutral↗ 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 · 7d agoRegulatoryNegative↗ source
  • Ipsen's Bylvay fails Phase 3 trial in children with biliary atresia
    Ipsen announced that its experimental therapy Bylvay did not meet its primary endpoint in a Phase 3 trial targeting biliary atresia in infants. Biliary atresia is a rare pediatric liver disorder i…
    Endpoints · 7d agoNegative readoutNegative↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 11d ago↗ source
  • FDA rejects Hengrui-Elevar liver cancer drug combo for third time
    For the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat th…
    Endpoints · 21d ago↗ source
  • City Therapeutics gets $99M to gather data on three RNAi medicines
    City Therapeutics, the next-gen RNAi startup founded and led by former Alnylam executives, has collected $99.5 million to fund the clinical development of its first three candidates and expand into…
    Endpoints · 1mo ago↗ source
  • GSK inks multi-target pact with Engitix; Sangamo considers strategic options
    Plus news about Pfizer's latest label expansion. 🤝 GSK inks multi-target liver pact with Engitix: London-based Engitix will use disease models based on its extracellular matrix technology to ident…
    Endpoints · 1mo ago↗ source
  • #ASCO26: AstraZeneca's triplet combo succeeds in liver cancer subgroup
    CHICAGO — AstraZeneca on Monday reported data from a new study showing the combination of a targeted treatment and two immunotherapies can benefit patients with certain kinds of liver cancer. Indiv…
    Endpoints · 2mo ago↗ source
  • Amgen stands by rare disease drug Tavneos amid Japan liver toxicity report
    The FDA wants it off the market. European regulators are investigating data-integrity concerns. And now, a pharma company selling the drug in Japan is warning doctors against writing new prescripti…
    Endpoints · 2mo ago↗ source
  • Patient Selection for Radiopharmaceuticals in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss how patient selection and disease characteristics influence the use of radiopharmaceuticals in metastatic castration-resistant prostate cancer (mCRPC).
    onclive · 2mo ago↗ source
  • Honesty and Humor Provide Hope in Breast Cancer Survivorship: With Sara Nunnery, MD, MSCI; and Annie Bond
    Dr Nunnery and Annie Bond discuss breast cancer survivorship and patient advocacy.
    onclive · 2mo ago↗ source
  • GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026
    We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.
    onclive · 2mo ago↗ source
  • Rezdiffra is exceeding Wall Street's expectations as the MASH market takes shape
    It seems there’s room for two in the MASH market. When Novo Nordisk’s blockbuster weight loss drug Wegovy won approval in August 2025 to treat the fatty liver disease, some investors thought it wou…
    Endpoints · 2mo ago↗ source
  • The OncFive: Top Oncology Articles for the Week of 5/3
    The FDA clears zenocutuzumab in NRG1 fusion+ cholangiocarcinoma, accepts a taletrectinib NDA in ROS1+ NSCLC for review, and more.
    onclive · 2mo ago↗ source
  • Dr Randall on Long-Term Responses and Functional Benefits With Pimicotinib in TGCT
    R. Lor Randall, MD, FACS discusses safety and efficacy data from the MANEUVER trial, which evaluated pimicotinib in TGCT.
    onclive · 2mo ago↗ source
  • Dr Sznol on Biomarkers of Response in Metastatic Melanoma
    Mario Sznol, MD, discusses the uncertainties around predicting benefit with immune checkpoint inhibitors in metastatic melanoma.
    onclive · 2mo ago↗ source
  • Intercept's next-gen FXR agonist fails Phase 2 in latest setback for Italian-owned pharma
    Intercept Pharmaceuticals' attempt at creating a next-generation FXR agonist for certain forms of liver inflammation appears to have ended. The drug developer's INT-787 showed "no clear evidence of…
    Endpoints · 2mo ago↗ source
  • Madrigal extends MASH deal streak with Arrowhead drug that J&J didn't want
    Madrigal Pharmaceuticals has made its fourth MASH deal in 10 months, further signaling its ambitions to be not just the first drugmaker for the fatty liver disease, but also the owner of the field'…
    Endpoints · 2mo ago↗ source