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21 stories matching this filter · ← front page

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STAT885Endpoints684BioPharma Dive258onclive165BioSpace134Fierce Biotech123globenewswire health49raps
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  • Five BioSpace NextGen companies debut on US markets in 2026, four actively hiring
    BioSpace NextGen honorees accounted for about one third of the 14 U.S. biotech companies that went public in 2026. The five companies together raised roughly $1.5 billion in IPO proceeds, includin…
    BioSpace · 1d agoPositive↗ source
  • Aurora Therapeutics drops PKU program and trims staff
    Aurora Therapeutics, a gene-editing startup founded by Jennifer Doudna, announced it is abandoning its lead phenylketonuria (PKU) program. The decision follows growing competition in the PKU field…
    BioSpace · 23h agoLayoffsNegative↗ source
46
fda recalls31
fda press22
fda medwatch21
630
Vaccines570
Endocrinology & Metabolism310
Ophthalmology284
Infectious Disease279
Pain273
  • 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 · 23h agoLayoffsNegative↗ source
  • Phase 3 failure of AstraZeneca/Ionis antisense drug Wainua shakes ATTR-CM market, opens space for other developers
    AstraZeneca and Ionis Pharmaceuticals reported that their antisense therapy Wainua did not achieve a significant cardiovascular benefit in a Phase 3 trial for transthyretin amyloid cardiomyopathy (…
    BioSpace · 3d agoNegative readoutNeutral↗ source
  • Moderna sticks to 10% revenue growth goal despite Phase 3 norovirus vaccine miss
    Moderna said it will continue to aim for up to 10% revenue growth this year, even though its experimental norovirus vaccine did not achieve statistical significance in a Phase 3 interim analysis.…
    BioSpace · 5d agoNegative readoutNeutral↗ 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 · 7d agoDealPositive↗ source
  • 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 · 8d agoNegative readoutNeutral↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 9d agoPositive readoutPositive↗ 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 · 12d 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 · 12d 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 · 17d 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 · 26d ago↗ source
  • FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
    On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ag…
    fda press · 1mo 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
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 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
  • 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
  • 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 · 3mo 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 · 3mo ago↗ source