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  • 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
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Psychiatry & CNS737
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Endocrinology & Metabolism390
Infectious Disease369
  • 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
  • B. Braun pulls spinal anesthesia kits after recall of bupivacaine in dextrose injection
    B. Braun Medical, Inc. has issued a recall of several spinal anesthesia convenience kits that contain Huons bupivacaine hydrochloride in dextrose injection. The recall follows a request from Huons…
    fda medwatch · 1mo agoCRLNegative↗ 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
  • 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
  • Arrow International issues correction for convenience kits containing recalled saline, lidocaine and bupivacaine
    Arrow International, a Teleflex subsidiary, sent a correction notice to customers about certain convenience kits. The kits contain 10 mL saline ampules, lidocaine and bupivacaine. The FDA classifi…
    fda medwatch · 1mo agoCRLNeutral↗ source
  • Merck-Kelun ADC sac-TMT shows progression-free survival benefit with Keytruda in late-stage NSCLC trial
    Kelun-Biotech announced that its antibody‑drug conjugate sac‑TMT, developed with Merck, achieved positive Phase 3 results when paired with Keytruda in a non‑small cell lung cancer trial. The data…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • J&J restructures pharma supply chain, offloading sites as part of $55 B U.S. manufacturing push
    Johnson & Johnson announced it is restructuring its pharmaceutical supply chain, offloading certain sites to streamline operations as part of its $55 billion U.S. manufacturing initiative. The cha…
    BioSpace · 1mo agoPositive↗ source
  • FDA issues early alert on Resmed Astral ventilators due to electrical component failure risk
    The FDA’s Center for Devices and Radiological Health has released an early alert warning about a possible high-risk problem with certain Resmed Astral ventilators. A defective electrical component…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • FDA acting commissioner says Makary’s journal policies are not official guidance; UK regulator reports rise in drug approvals and AI steps
    The acting commissioner of the U.S. Food and Drug Administration clarified that the policies published in medical journals by former commissioner Marty Makary do not constitute official FDA policy…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA Grants Emergency Use Authorization for Ivermectin Liquid to Prevent New World Screwworm in Horses
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for an ivermectin oral solution intended for horses, aimed at preventing infestations by New World screwworm. The au…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Experts say MDUFA VI draft letter improves program while addressing FDA resource limits
    Industry experts note that the draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) offers enhancements over the current framework and takes into account the FDA’s…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Baxter issues urgent correction for Volara breathing device circuits due to leak risk
    Baxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use. The…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Medtronic recalls Harmony delivery catheter system after tip detachment risk
    Medtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve. The FDA classified the recall as th…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networks
    The FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
    fda press · 1mo agoRegulatoryPositive↗ source
  • FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kits
    FDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile. Medline sent a letter on June 12…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
    The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit. The alert says that particulates coul…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug
    The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of t…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 1mo agoCRLNegative↗ source