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  • San Diego biotech BlossomHill files for IPO to fund EGFR lung-cancer drug program
    BlossomHill Therapeutics, a San Diego oncology biotech focused on small‑molecule drugs, has filed an S‑1 registration statement to become a public company. The company, founded in February 2024 by…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Insmed's inhaled PAH therapy shows durable efficacy in 12-month extension, bolstering $6B sales outlook
    Insmed reported that its inhalable prostanoid candidate, treprostinil palmitil inhalation powder (TPIP), maintained functional and biomarker benefits through a 12‑month open‑label extension in pati…
    BioSpace · 1mo agoPositive readoutPositive↗ source
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Endocrinology & Metabolism387
Infectious Disease361
  • FDA says former officials' journal articles do not represent agency policy after lawmaker criticism
    Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulat…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Jasper Therapeutics merges with Kira Pharmaceuticals, divests Tavneos rival to Mirador
    Jasper Therapeutics announced a merger with Nasdaq‑listed Kira Pharmaceuticals, positioning the combined company for a fresh strategic direction. The deal follows a difficult period for Jasper, whi…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • GSK halts camlipixant development after mixed Phase 3 results curb blockbuster hopes
    GSK announced it is stopping work on camlipixant, a P2X3 receptor antagonist it bought when acquiring Bellus Health in 2023, after the drug produced mixed results in two Phase 3 chronic cough trial…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Biotronik Neuro acquires Soin Neuroscience spinal cord stimulation patent portfolio to boost next-gen pain therapy
    Biotronik Neuro, the neuromodulation arm of Berlin-based medtech firm Biotronik, announced it has purchased a collection of spinal cord stimulation patents from Ohio-based Soin Neuroscience. The a…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA proposal to drop adequate provision could effectively ban prescription drug ads
    FDA staff are proposing to eliminate the adequate provision requirement in direct-to-consumer prescription-drug advertisements. The adequate provision currently obliges advertisers to present a bal…
    raps · 1mo agoRegulatoryNegative↗ source
  • Pharma industry backs FDA NGS guidance but seeks clarification on off-target data and manufacturing changes
    The pharmaceutical sector has broadly endorsed the FDA's recent guidance on using next‑generation sequencing to evaluate the safety of human gene‑therapy products. Despite this support, companies…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA staff flag peptide conflict concerns and warn drug ad rule could curb advertising
    FDA staff have raised internal concerns about potential conflicts of interest among experts who will sit on an upcoming advisory panel reviewing peptide therapies. The staff memo warns that undiscl…
    raps · 1mo agoRegulatoryNegative↗ source
  • Fierce Biotech flags five cities poised to become next biotech powerhouses
    Fierce Biotech’s latest special report identifies five cities that could emerge as major biotech hubs. The podcast episode of “The Top Line” highlights Boston, San Francisco, Beijing, Seattle and C…
    Fierce Biotech · 1mo agoPositive↗ source
  • Merck wins FDA nod for first oral PCSK9 inhibitor, Lipfendra, to treat high LDL cholesterol
    Merck announced that the U.S. Food and Drug Administration has approved its once-daily oral PCSK9 inhibitor, enlicitide, marketed as Lipfendra, for adults with elevated LDL cholesterol. The drug i…
    BioSpace · 1mo agoApprovalPositive↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 1mo agoApprovalPositive↗ source
  • Eli Lilly to acquire AtaiBeckley in up to $3.8 billion deal, entering psychedelics market
    Eli Lilly announced it will buy AtaiBeckley, offering $6.75 per share for the company’s common stock. The transaction includes an upfront commitment of about $2.8 billion and a contingent value rig…
    BioSpace · 1mo agoDealPositive↗ source
  • Takeda's zasocitinib clears scalp psoriasis in 75% of patients in phase 3 data
    Takeda released updated results from its two phase 3 trials of the oral TYK2 inhibitor zasocitinib, enrolling a total of 1,801 patients with moderate-to-severe plaque psoriasis. The data showed th…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • InnoCare’s TYK2 inhibitor soficitinib meets primary endpoint in phase 2 vitiligo trial
    InnoCare Pharma announced that its TYK2 inhibitor soficitinib achieved the primary endpoint in a phase 2 study of non‑segmental vitiligo conducted at sites in China. The trial evaluated daily oral…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Biopharma layoffs may exceed 14,000 jobs in H1 as Takeda, BioNTech and Viatris cut staff
    Biopharma firms are preparing for a wave of job cuts in the first half of 2026, with total layoffs projected to affect more than 14,000 employees, according to data compiled by BioSpace. The bulk…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • FDA issues first AI-focused cGMP warning letter, flagging oversight gaps for manufacturers
    The FDA has issued its first warning letter that explicitly addresses the use of artificial intelligence in pharmaceutical manufacturing, targeting Purolea Cosmetics Lab. The letter cites AI‑gener…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Three biotech firms launch IPOs to challenge giants in cardiometabolic and immunology markets
    Braveheart Bio, Attovia Therapeutics and Vogenx filed for initial public offerings this week, adding to a surge of biotech listings in 2026. Braveheart is developing a therapy for hypertrophic car…
    BioSpace · 1mo agoDealNeutral↗ source
  • Podcast explores non-opioid and regenerative approaches to pain relief
    In a recent episode of the Denatured podcast, Lance Alstodt, chairman and CEO of BioRestorative Therapies, and Paul Mieyal, chief business officer of South Rampart Pharma, discuss why pain remains…
    BioSpace · 1mo agoPositive↗ source
  • J&J reports 40% Q2 sales jump for Spravato as psychedelic rivals loom
    Johnson & Johnson said its depression nasal spray Spravato generated $584 million in worldwide revenue in the second quarter, a 40% increase from a year earlier. The company highlighted the drug as…
    BioSpace · 1mo agoEarningsNeutral↗ source
  • Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority
    Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EMA issues guidance to curb microbial contamination in non-sterile medicines; MHRA reports record drug approvals
    The European Medicines Agency has issued new guidance that outlines technical and organisational measures to reduce the risk of microbial contamination in non-sterile pharmaceutical products. The…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 1mo agoPositive↗ source
  • UK regulator reports rise in drug approvals and steps toward AI oversight in healthcare
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines this year than in t…
    raps · 1mo agoRegulatoryNeutral↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 1mo agoNeutral↗ source