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1,142 stories matching this filter · ← front page

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  • LifeMine Therapeutics secures $263 million in dual venture rounds to advance organ transplant aftercare drug
    LifeMine Therapeutics announced it has raised a total of $263 million through a $75 million Series D and an $188 million Series F round, opting for private financing rather than an IPO. The capita…
    BioSpace · 3mo agoDealPositive↗ source
  • FDA approves first drug for type 1 narcolepsy and greenlights mRNA flu vaccine; AstraZeneca and BMS deny merger talks
    The U.S. Food and Drug Administration has granted approval for the first therapy specifically targeting type 1 narcolepsy, marking a milestone for patients with this rare sleep disorder. In a sepa…
    raps · 3mo agoApprovalPositive↗ source
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fda medwatch109
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Psychiatry & CNS1197
Ophthalmology1035
Endocrinology & Metabolism774
Pain768
Nephrology758
  • 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 · 3mo agoDealPositive↗ source
  • Sanofi pauses Phase 2 bronchiectasis study of SAR445399 amid new CEO’s portfolio review
    Sanofi has halted a Phase 2 trial of its investigational antibody SAR445399 in non‑cystic fibrosis bronchiectasis. The pause was attributed to strategic business reasons linked to an internal portf…
    BioSpace · 3mo agoRegulatoryNeutral↗ 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 · 3mo agoRegulatoryNeutral↗ source
  • BioVie shares plunge as Parkinson’s trial results lack primary motor data
    BioVie reported results of its Phase 2 SUNRISE-PD study in early‑stage Parkinson’s disease. The double‑blind, placebo‑controlled trial enrolled 57 patients who had not yet received carbidopa/levodo…
    BioSpace · 3mo agoNegative readoutNegative↗ source
  • Podcast explores emerging rapid‑acting and psychedelic therapies for treatment‑resistant depression
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer C. Smith‑Parker talks with Hans Eriksson, chief medical officer of FundaMental Pharma, and Steve Levine, chief patient officer at…
    BioSpace · 3mo agoPositive↗ source
  • Choosing Between CROs and Biotechs: How Company Size Shapes the Fit
    While biotechs and contract research organizations each have strengths, the article notes that the right choice depends on a company’s specific situation. Ali Pashazadeh, founder and CEO of Treehi…
    BioSpace · 3mo 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 · 3mo agoRegulatoryNeutral↗ 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 · 3mo 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 · 3mo agoRegulatoryNeutral↗ source
  • Lilly's Foundayo obesity pill posts $98 million Q2 sales, trails Novo's Wegovy
    Eli Lilly introduced its oral obesity treatment Foundayo after receiving FDA approval in April 2025. The drug entered the market in the second quarter of 2026, marking Lilly's first foray into an o…
    BioSpace · 3mo agoNegative readoutNeutral↗ source
  • Analysts spot several biotech firms as likely M&A targets amid rising pharma deal activity
    Pharma companies are actively looking for acquisition opportunities, and analysts have identified a handful of biotech firms that could be next in line for buyouts. Recent transactions have center…
    BioSpace · 3mo agoDealNeutral↗ source
  • FDA approves Orzeyful, first drug to treat all symptoms of narcolepsy type 1
    The U.S. Food and Drug Administration announced on August 5, 2026 that it has approved Orzeyful (oveporexton) tablets for adults with narcolepsy type 1. Orzeyful is the first therapy cleared to tr…
    fda press · 3mo agoApprovalPositive↗ source
  • AstraZeneca and BMS deny merger talks, Reuters says no deal
    Reuters reported that rumors of a merger between AstraZeneca and Bristol Myers Squibb have been dismissed. A senior source close to the matter told Reuters there is no deal and no discussions betw…
    BioSpace · 3mo agoDealNeutral↗ source
  • Over a third of biotech and pharma workers stay in their jobs for health insurance, poll shows
    A recent BioSpace LinkedIn poll and a joint study by West Health and Gallup found that a significant share of biotech and pharma employees remain in their current roles primarily to keep health ins…
    BioSpace · 3mo agoNegative↗ source
  • FDA advisory committee meetings sow confusion, threaten trust with rare disease developers
    The Food and Drug Administration has been working to repair its relationship with rare-disease drug makers and patient groups since former commissioner Marty Makary left three months ago. Last wee…
    BioSpace · 3mo agoRegulatoryNegative↗ source
  • Gilead pushes into inflammation and oncology as it seeks to diversify beyond HIV franchise
    Gilead reported that HIV remained its strongest franchise in the second quarter, but the company is actively building a pipeline outside virology. CEO Daniel O’Day told investors that diversificat…
    BioSpace · 3mo agoNeutral↗ source
  • Amgen drops Phase 1 obesity drug AMG 513, leaving MariTide as its only weight-loss candidate and eyes early-stage deals
    Amgen announced it is halting development of AMG 513, a Phase 1 obesity therapy, leaving MariTide as its sole weight‑loss asset. The company said its late‑stage pipeline is largely full, so future…
    BioSpace · 3mo agoDealNeutral↗ source
  • Novo Nordisk CEO says innovation is essential as pipeline faces setbacks
    During Novo Nordisk's second-quarter earnings call, CEO Maziar Mike Doustdar said that failure is a normal part of drug development and emphasized that the company's survival depends on continual i…
    BioSpace · 3mo agoEarningsNeutral↗ source
  • Merger talks between Bristol Myers Squibb and AstraZeneca fade as Q2 earnings roll out and FDA advisory meetings heat up
    Talks of a possible merger between Bristol Myers Squibb and AstraZeneca have receded after analysts highlighted antitrust hurdles. Both companies, each valued over $130 billion, were rumored to con…
    BioSpace · 3mo agoDealNeutral↗ source
  • 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 · 3mo 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 · 3mo agoLayoffsNegative↗ source
  • Novo Nordisk shares slide 6% after Wegovy pill sales miss despite earnings beat
    Novo Nordisk reported second‑quarter results that beat both revenue and profit forecasts, posting a profit of $5.15 billion. The company’s oral Wegovy obesity pill generated $496 million in sales,…
    BioSpace · 3mo agoEarningsNegative↗ source
  • BioNTech trims full-year COVID-19 vaccine sales outlook by up to 20% amid weak demand
    BioNTech announced it is lowering its full-year sales guidance for its COVID-19 vaccine. The company cut the midpoint of its outlook by almost 20%, moving the range to €1.6-1.9 billion from the pr…
    BioSpace · 3mo agoEarningsNegative↗ source