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1,288 stories matching this filter · ← front page

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  • FDA releases FY 2027 user fee rates and updates guidance for injectable peptide ANDAs
    The U.S. Food and Drug Administration has published its user fee rates for fiscal year 2027, covering prescription drugs, generics, biosimilars, medical devices and over‑the‑counter products. The r…
    raps · 26d agoRegulatoryNeutral↗ source
  • Regeneron and Sanofi explore expanded partnership for Dupixent follow-on candidates
    Regeneron and Sanofi said they are in early discussions about expanding their collaboration beyond the existing Dupixent partnership. The companies indicated the potential scope could include deve…
    Endpoints · 25d agoDealPositive↗ source
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  • Replimune argues its oncolytic virus plus checkpoint inhibitor benefits advanced melanoma patients at FDA advisory meeting
    Replimune presented data from its pivotal advanced melanoma trial to an FDA advisory committee. The company defended the trial design and results, emphasizing the added benefit of its oncolytic vi…
    Endpoints · 25d agoRegulatoryNeutral↗ source
  • EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech Act
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being c…
    raps · 26d agoRegulatoryNeutral↗ source
  • Takeda, Regeneron, Sanofi and Bristol Myers Squibb announce pipeline cuts in quarterly updates
    Takeda, Regeneron, Sanofi and Bristol Myers Squibb disclosed that they are trimming several drug development programs as part of their recent earnings releases. The cuts affect a mix of early‑stage…
    Endpoints · 26d agoNeutral↗ source
  • Gerresheimer sells Centor and Primary Packaging Plastics units to Apax Partners for €1.5 billion
    Gerresheimer announced it is divesting two of its businesses, the Centor unit and the Primary Packaging Plastics (PPP) unit, to private‑equity firm Apax Partners. The transaction is valued at rough…
    Endpoints · 26d agoDealNeutral↗ source
  • Leo International Precision Health AG board member Leo Wang buys shares worth €55,933
    Leo International Precision Health AG announced that board member Leo Wang has purchased shares of the company. The transaction involved shares with ISIN DE0005490601 and was executed on July 27, 2…
    globenewswire health · 26d agoDealNeutral↗ source
  • Leo International Precision Health AG discloses insider share acquisition by board member Leo Wang
    Leo International Precision Health AG announced that Leo Wang, a member of its administrative or supervisory body, has purchased shares of the company. The transaction involved a total considerati…
    globenewswire health · 26d agoDealNeutral↗ source
  • Trump's CDC nominee Erica Schwartz clears key Senate committee vote
    Erica Schwartz, a former deputy surgeon general, was nominated by the Trump administration to lead the CDC. On July 15, 2026 she testified before the Senate Health, Education, Labor and Pensions C…
    Endpoints · 26d agoRegulatoryNeutral↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 27d agoEarningsPositive↗ 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 · 27d 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 · 27d 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 · 26d 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 · 26d 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 · 26d 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 · 26d 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 · 26d 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 · 27d 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 · 27d agoPositive readoutPositive↗ 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 · 27d agoEarningsPositive↗ 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 · 26d 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 · 27d 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 · 27d agoDealNeutral↗ source
  • AI startup Doctronic acquires text-message pediatric care provider Summer Health
    Doctronic, a startup that markets itself as an AI doctor, announced it has purchased Summer Health, a company that offers pediatric care via text messaging. The acquisition expands Doctronic’s ser…
    Endpoints · 27d agoDealNeutral↗ source
  • Nokia reports senior executive Kristen Pressner purchases 66,324 shares at €7.84 each
    Nokia Oyj filed a market abuse regulation disclosure on July 29, 2026 indicating that senior executive Kristen Pressner bought shares of the company. The transaction involved 66,324 ordinary share…
    globenewswire health · 27d agoDealNeutral↗ source