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  • Attovia, Braveheart and Vogenx seek more than $500M across trio of IPOs
    Attovia Therapeutics, Braveheart Bio and Vogenx have set target ranges for their IPOs, positioning the trio to collectively net more than $500 million from public investors.
    Fierce Biotech · 15h ago↗ source
  • Labcorp posts higher Q2 earnings on strength of diagnostics, lab services; adjusts full-year guidance
    Labcorp continues to power along as it posts strong quarterly earnings led by growth in its diagnostics and lab services and triggering the medtech to raise its full-year guidance.
    Fierce Biotech · 16h ago↗ source
  • Takeda scraps another phase 2 celiac disease therapy, narrowing pipeline to one
    Takeda has dropped another celiac disease therapy from its phase 2 pipeline, leaving the company with just one shot at treating the condition.
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Ophthalmology138
Endocrinology & Metabolism119
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Nephrology111
Fierce Biotech · 16h ago
↗ source
  • GSK pens $110M biological datasets pact with AI biotech Relation
    GSK is boosting its AI chops with a new deal worth up to $110 million with Relation.
    Fierce Biotech · 17h ago↗ source
  • Boston Scientific cuts guidance again after unveiling restructuring plan
    Boston Scientific is cutting its financial guidance for the second quarter in a row as it gears up for a tough six months ahead.
    Fierce Biotech · 20h ago↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 1d agoApprovalPositive↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 1d agoNegative readoutNegative↗ source
  • FTC sues Hims & Hers over alleged health data sharing and deceptive billing practices
    The Federal Trade Commission filed a lawsuit against Hims & Hers, a telehealth company based in San Francisco, accusing it of improper handling of patient information. According to the complaint,…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • US releases $600M pledged to global vaccine alliance Gavi after year‑long delay
    The United States has released the $600 million it pledged to Gavi, the global vaccine alliance. The funds had been held in limbo for about a year before the Treasury completed the transfer. Sena…
    Endpoints · 1d agoDealPositive↗ source
  • FDA and Capricor clash over Duchenne cell therapy efficacy at advisory committee
    At an FDA advisory committee meeting, the agency and Capricor Therapeutics presented conflicting views on the efficacy data for the company's experimental cell therapy aimed at Duchenne muscular dy…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Atea's hepatitis C combo therapy shows non-inferior results to Gilead's Epclusa
    Atea Pharmaceuticals announced that its oral combination of bemnifosbuvir and ruzasvir met the predefined non-inferiority criteria when compared with Gilead's Epclusa for treating hepatitis C. The…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Novo Nordisk loses bid to dismiss lawsuit over CagriSema trial readout
    U.S. District Judge Robert Kirsch in New Jersey refused to dismiss most of the securities lawsuit filed by investors after Novo Nordisk’s CagriSema readout. While the judge found the plaintiffs’ cl…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Processa Pharma acquires Vidya Therapeutics, gaining oral BTK inhibitor VT-7208
    Processa Pharmaceuticals announced an all‑stock acquisition of Vidya Therapeutics, a Florida biotech developing an oral BTK inhibitor called VT‑7208. VT‑7208 is being positioned as a next‑generati…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Leqembi posts $184M Q2 sales, best quarter since launch, Biogen lifts guidance
    Leqembi, the anti-amyloid Alzheimer’s drug co-developed by Eisai and Biogen, generated $184 million in global sales in the second quarter, according to Biogen. The Q2 figure represents the stronge…
    Endpoints · 1d agoEarningsPositive↗ source
  • Caldera Therapeutics completes reverse merger with Synlogic, secures $278 million financing
    Caldera Therapeutics, a Massachusetts biotech founded last year, announced a reverse merger with Nasdaq-listed Synlogic, giving it a public listing. The transaction includes a $278 million financi…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Teva says it has time to prepare for upcoming US tariffs on imported generic drugs
    Teva CEO Richard Francis said the company believes it has sufficient time to prepare for the tariffs the Trump administration is considering on generic drugs imported from outside the United States…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 1d agoDealNeutral↗ source
  • Two biotech firms announce reverse mergers to list experimental bispecific antibody and BTK inhibitor on Nasdaq
    Two biotech companies have each entered reverse merger agreements to become publicly traded on Nasdaq. One firm, based in China, is developing a bispecific antibody and will use the merger to brin…
    Endpoints · 1d agoDealNeutral↗ source
  • Nanoparticle-loaded chemotherapy crosses blood-brain barrier in mice after glioblastoma surgery, study shows
    Researchers at the University of Manchester have demonstrated that a standard chemotherapy drug can reach the brain when packaged in liposome nanoparticles and given shortly after tumor removal in…
    Fierce Biotech · 1d agoPositive↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Vertex pays $28 million upfront to AbCellera for autoimmune T-cell engager collaboration
    Vertex Pharmaceuticals has entered a collaboration with AbCellera, paying an upfront sum of $28 million to access the latter’s T-cell engager platform for autoimmune disease programs. Under the ag…
    Fierce Biotech · 1d agoDealNeutral↗ source