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987 stories matching this filter · ← front page

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STAT1772Endpoints1378Fierce Biotech697BioSpace689BioPharma Dive522raps231onclive165fda recalls111
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allOncology12280Rare Disease3178Immunology2859Cardiology2719Hematology2154Pulmonology2135Vaccines1787
  • MapLight shares tumble over 60% after mixed Phase 2 schizophrenia trial results
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the experimental schizophrenia drug ML-007C-MA, causing its stock to fall sharply. The trial enrolled 307 patients wi…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source
  • InnoCare’s oral TYK2 inhibitor fadeucravacitinib meets primary endpoint in phase 3 psoriasis trial
    InnoCare Pharma announced that its oral TYK2 inhibitor fadeucravacitinib (also known as ICP-488) achieved the primary endpoint in a phase 3 study of adults with moderate-to-severe plaque psoriasis.…
    Fierce Biotech · 3mo agoPositive readoutPositive↗ source
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fda medwatch109
globenewswire health73
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Ophthalmology1036
Endocrinology & Metabolism775
Pain768
Nephrology758
  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 3mo agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Gossamer ends $486M PAH partnership with Chiesi after phase 3 miss
    Gossamer Bio announced it is terminating its collaboration and licensing agreement with Italy's Chiesi, regaining worldwide development and commercial rights to its pulmonary arterial hypertension…
    Fierce Biotech · 3mo agoDealNegative↗ source
  • AstraZeneca says it remains confident in its ADC pipeline after dropping two underperforming candidates
    AstraZeneca executives told Fierce they are very confident in their internally developed antibody‑drug conjugate (ADC) program despite recent setbacks. The company has discontinued two ADC candida…
    Fierce Biotech · 3mo agoNegative readoutNeutral↗ source
  • Labcorp unveils direct-to-consumer genetic health panel covering 163 genes and 100+ conditions
    Labcorp announced the launch of a new direct-to-consumer test called the Marker by Labcorp Genetic Health Panel. The panel examines 163 genes to assess risk for more than 100 hereditary conditions…
    Fierce Biotech · 3mo agoPositive↗ source
  • Study shows drug development and reimbursement timelines align across four major markets
    Researchers published a cross‑sectional analysis in JAMA Health Forum examining how long it takes for a drug to move from the start of clinical trials to receiving reimbursement approval. The anal…
    raps · 3mo agoNeutral↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Legend Biotech CEO Ying Huang resigns, interim leader Alan Bash appointed
    Legend Biotech announced that its chief executive, Ying Huang, Ph.D., stepped down on Friday, with no permanent successor named yet. The board named Alan Bash as interim CEO on July 23, according…
    Fierce Biotech · 3mo agoNeutral↗ source
  • Genetic markers linked to Yescarta toxicity identified, opening path to safer CAR-T designs
    Researchers analyzed data from patients who received Kite Pharma's Yescarta CAR-T therapy in clinical trials. The analysis uncovered specific genetic signatures that correlate with higher risk of…
    Fierce Biotech · 3mo agoPositive readoutPositive↗ source
  • Amgen cuts about 40 jobs, about 0.1% of workforce, amid ongoing challenges
    Amgen announced the layoff of roughly 40 employees, representing about 0.1% of its global staff, as part of organizational changes aimed at aligning operations with strategic objectives. The compan…
    Fierce Biotech · 3mo agoLayoffsNegative↗ source
  • Merck launches voluntary licensing for investigational monthly HIV PrEP pill ahead of approval
    Merck has signed voluntary licensing agreements to allow generic manufacturers to produce its investigational monthly HIV PrEP pill, alimatravir, before any regulatory submission. The agreements c…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Sanofi drops pursuit of eczema drug amlitelimab after failed Phase 3 trials
    Sanofi announced it will no longer seek regulatory approval for amlitelimab, an anti‑OX40 ligand antibody intended for atopic dermatitis, after recent Phase 3 data fell short of expectations. The…
    Fierce Biotech · 3mo agoRegulatoryNegative↗ source
  • Scribe Therapeutics upsizes IPO to $128.7 million to fund lipid-lowering gene therapy
    Scribe Therapeutics announced pricing its initial public offering at $128.7 million, surpassing the $96 million target it had set earlier in the week. The company sold 8.6 million shares at $15 ea…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Eli Lilly’s retatrutide meets primary goals in phase 3 obesity trials with ~22% weight loss but no clear heart benefit
    Eli Lilly reported that its triple‑hormone agonist retatrutide achieved the primary endpoints in two phase 3 obesity studies, TRIUMPH‑2 and TRIUMPH‑3. The drug was tested at a 12 mg dose against pl…
    Fierce Biotech · 3mo agoPositive readoutNeutral↗ source
  • Scancell to list on Nasdaq after reverse merger with Neuphoria, funds $89M for melanoma immunotherapy trial
    Scancell announced that it will become a publicly traded company on Nasdaq after completing an all‑stock reverse merger with Neophobia Therapeutics. The transaction gives Scancell a new ticker, SCL…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Most FDA-approved drugs meet postmarketing study requirements, and advisory panel backs two peptides for bulk compounding
    A recent analysis published in JAMA Network Open found that nearly nine out of ten drugs approved by the U.S. Food and Drug Administration have completed their postmarketing requirements or commitm…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Biotech hubs from Abu Dhabi to Brazil compete to become the next emerging economy
    Fierce reporters attended the Biotechnology Innovation Organization conference in San Diego to gauge how biotech hubs worldwide are positioning themselves amid tariff concerns and China’s growing i…
    Fierce Biotech · 3mo agoNeutral↗ source
  • Roche halts lupus T-cell engager RG6382 development after early trial review
    Roche announced it is stopping work on RG6382, a bispecific T-cell engager targeting CD19 and CD3, which was being tested in a phase‑1 study in patients with systemic lupus erythematosus (SLE). Th…
    Fierce Biotech · 3mo agoNegative↗ source
  • FDA approves Johnson & Johnson's Ottava robotic system for multiple soft-tissue surgeries
    FDA cleared Johnson & Johnson's Ottava robotic surgical system, marking its entry into the market. The clearance covers a range of soft-tissue procedures such as gastric bypass, gastrectomy, chole…
    Fierce Biotech · 3mo agoApprovalPositive↗ source
  • Roche Diagnostics sales rise only 3% in H1 2026 as China pricing reforms weigh
    Roche Diagnostics reported sales of 6.73 billion Swiss francs for the first half of 2026, a 3% increase at constant exchange rates but a 3% decline in reported franc terms. Growth was limited by p…
    Fierce Biotech · 3mo agoEarningsNegative↗ source