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2,283 stories matching this filter · ← front page

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  • FDA issues rule to allow non-animal testing methods for drug safety
    FDA issued a direct final rule that updates its regulations to clarify that non-animal methods may be used for safety testing of drugs and biological products before they are tested in humans. The…
    fda press · 1mo agoRegulatoryPositive↗ source
  • New KRAS-targeting drug daraxonrasib approved for pancreatic cancer as experts call for $100 billion NIH budget
    The FDA has approved daraxonrasib, a therapy from Revolution Medicines that targets the KRAS mutation in pancreatic cancer. The drug is intended for patients who have already received treatment and…
    STAT · 1mo agoApprovalPositive↗ source
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  • Experts see Replimune’s Tudriqev approval as a step toward broader use of localized cancer therapies
    Replimune received FDA approval last month for Tudriqev, an oncolytic virus injected directly into melanoma tumors, marking only the second such approval for a therapy delivered straight into a tum…
    BioSpace · 1mo agoApprovalPositive↗ source
  • Transposase-based cell line platform speeds development and raises protein yields for complex biologics
    Advanced cell line development tools are helping biopharma tackle the expression and stability challenges of increasingly complex molecules such as bispecifics and trispecifics. The article highli…
    BioSpace · 1mo agoPositive↗ source
  • Congress pushes back on White House plan to place political appointees on NIH grant reviews
    Members of Congress have voiced strong opposition after a leak revealed a White House proposal to create a commission of political appointees that would review every NIH grant. The idea reportedly…
    STAT · 29d agoRegulatoryNegative↗ source
  • Global Mix Inc. recalls Niwali Tejocote supplements after FDA finds toxic yellow oleander content
    Global Mix Inc., based in Middle Village, New York, announced a recall of its Niwali Tejocote Capsules and Pieces, both marketed as herbal dietary supplements. The FDA’s analysis indicated the pro…
    fda recalls · 29d agoRegulatoryNegative↗ source
  • Sleuth predicts surge in Western licensing of Chinese radioligand therapies by 2027
    Sleuth, a biopharma intelligence platform, says that while Chinese radiopharmaceutical assets have seen few licensing deals so far, the market is set to change. The firm notes that China now runs…
    BioSpace · 29d agoNeutral↗ source
  • Novo outlines $23 billion 2035 revenue target, but investors react with a 7% share drop
    Novo’s chief executive used the recent Capital Markets Day to lay out a long‑term growth plan that targets $23 billion in annual sales by 2035. The strategy emphasizes expanding beyond its flagship…
    BioSpace · 1mo agoNegative↗ source
  • Novo acquires three early-stage obesity assets from Kallyope to broaden pipeline amid investor pressure
    Investors have been urging Novo to expand its pipeline beyond the semaglutide franchise that drives most of its sales. In response, Novo announced it will acquire three early-stage obesity candida…
    BioSpace · 1mo agoDealPositive↗ source
  • Alkermes' orexin agonist ALKS 7290 shows promise in early-stage ADHD trial
    Alkermes reported results from a Phase 1 study of its orexin agonist ALKS 7290, a drug class previously explored for rare sleep disorders. The trial enrolled adults with moderate to severe ADHD, a…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Novo Nordisk outlines new obesity and consumer-focused strategy, targets five multi-blockbusters by 2030
    Novo Nordisk used its capital markets day to reassure investors by unveiling a plan to broaden its pipeline beyond diabetes and obesity. The company said it will aim to launch at least five multi-b…
    STAT · 1mo agoNeutral↗ source
  • STAT launches first trust-in-science reporter to explore declining public confidence in health research
    Alex Hogan, senior multimedia producer at STAT, hosts the weekly video series STATus Report and recently aired an episode titled “Why is trust in science important?”. The episode notes that public…
    STAT · 1mo agoNeutral↗ source
  • FDA’s new CBER and CDER heads back adaptive framework for rare disease therapies
    Newly appointed permanent directors of FDA’s CBER and CDER, Karim Mikhail and Michael Davis, indicated they will continue the agency’s push for an adaptive regulatory framework aimed at rare diseas…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Addiction clinics see rising cases of kratom and 7-OH withdrawal
    Addiction clinics are seeing a surge in patients dependent on potent kratom and 7-OH products.
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Experts urge ClinicalTrials.gov to add pregnancy and lactation checkbox to aid trial enrollment
    Patients who are pregnant or nursing often struggle to locate clinical trials that accept them, and clinicians face the same obstacle when advising participants. ClinicalTrials.gov lists more than…
    STAT · 1mo agoPositive↗ source
  • Trump calls for new vaccine while echoing vaccine misinformation
    A recent STAT newsletter reported that President Donald Trump announced he will demand a new vaccine, echoing long-standing vaccine misinformation. The claim was made a day after health secretary R…
    STAT · 1mo agoNegative↗ source
  • STAT launches trust-in-science reporter to explore public skepticism of modern medicine
    STAT has added a new reporter, Nicholas Florko, to cover trust in science and examine why many people doubt modern medicine. Florko, who also deals with personal health issues such as high cholest…
    STAT · 1mo agoNeutral↗ source
  • Republican Iowa governor candidate teams with RFK Jr. as poll lag persists
    Zach Lahn, a farmer and Republican candidate, is running for Iowa governor and currently trails the Democratic opponent in recent polls. Lahn has highlighted his partnership with health secretary…
    STAT · 1mo agoNeutral↗ source
  • Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts
    Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
    BioSpace · 29d ago↗ source
  • Telix to acquire ITM Isotope Technologies in $1.65 billion radiopharma merger
    ITM Isotope Technologies Munich SE and Telix Pharmaceuticals announced a merger that will combine two leading radiopharmaceutical developers. The transaction is valued at a minimum of $1.65 billio…
    STAT · 1mo agoDealNeutral↗ source
  • Jehovah's Witnesses ease ban, permitting blood-derived products while still forbidding whole-blood transfusions
    The religious group announced a revision to its long-standing medical policy, now allowing members to receive products derived from donated blood. The new guidance says individuals may accept plas…
    STAT · 1mo agoNeutral↗ source
  • Ultragenyx receives FDA approval for Fayuvi, first therapy for Sanfilippo syndrome type A, priced at $3.95 M
    The FDA has approved Ultragenyx's gene therapy rebisufligene etisparvovec, to be sold under the brand name Fayuvi, for the treatment of Sanfilippo syndrome type A, an ultra-rare progressive neurolo…
    BioSpace · 1mo agoApprovalPositive↗ source
  • China unveils five-year plan to grow biotech sector from $3M to $522B by 2030
    China's Ministry of Industry and Information Technology released a new five-year biotech plan that sets out ambitious growth targets for the sector. The plan aims to expand the industry from rough…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Electra Therapeutics raises $350M in IPO to fund pivotal immune-disease antibody development
    Electra Therapeutics announced an initial public offering that raised $350 million, exceeding its earlier target. The IPO consisted of 23.3 million shares sold at $15 per share, and underwriters w…
    BioSpace · 1mo agoDealPositive↗ source
  • Xenon shares plunge 23% after voluntary hold on psychiatry trials, despite filing NDA for epilepsy drug
    Xenon Pharmaceuticals announced that its lead asset azetukalner (AZK) has been submitted to the FDA as a new drug application for focal onset seizures. At the same time, the company disclosed a vo…
    BioSpace · 1mo agoRegulatoryNegative↗ source