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  • 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
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
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Infectious Disease362
  • Mid-year roundup highlights top health-tech trends in 2026
    The editorial team notes that the first half of 2026 has been unusually active for health technology. Five major developments have been identified as the most significant so far. One clear theme i…
    Endpoints · 1mo agoNeutral↗ source
  • Catalent to sell its Nottingham oral solid dose facility to CDMO Codis
    Catalent announced it will divest its United Kingdom manufacturing site, selling the oral solid dose factory located in Nottingham. The buyer is Codis, a contract development and manufacturing org…
    Endpoints · 1mo agoDealNeutral↗ 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
  • Prime Medicine clears legal hurdle with Beam Therapeutics, moves AATD gene therapy toward clinic
    Prime Medicine announced it will advance its AATD gene editing candidate into clinical trials after arbitrators ruled in its favor in a dispute with Beam Therapeutics. The dispute centered on a 20…
    Endpoints · 1mo agoPositive↗ source
  • AstraZeneca and GSK strike new China partnerships with Sino Biopharm
    Sino Biopharm announced two separate agreements with the United Kingdom's largest drugmakers, AstraZeneca and GSK, to deepen their presence in the Chinese market. AstraZeneca will license rights t…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Novartis announces reduction of 322 jobs at New Jersey facility
    Novartis filed a WARN notice indicating it will eliminate 322 positions at its East Hanover, New Jersey site. The reduction is part of a broader restructuring effort aimed at streamlining operation…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • Arbitration panel rules Prime Medicine did not breach Beam deal over AATD therapy
    An arbitration panel has ruled that Prime Medicine did not violate its 2019 collaboration agreement with Beam Therapeutics by advancing a treatment for alpha‑1 antitrypsin deficiency (AATD). The de…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Sino Biopharm signs separate respiratory partnership deals with AstraZeneca and GSK
    Sino Biopharm announced it has entered into two distinct agreements with UK-based pharmaceutical companies focused on respiratory medicines. One agreement involves licensing its investigational PD…
    Endpoints · 1mo agoDealPositive↗ source
  • Satellos Bioscience presents early adult data for Duchenne muscular dystrophy pill ahead of child trial
    Satellos Bioscience, a Canadian biotech, has released early results from its Phase 2 study of an oral therapy for Duchenne muscular dystrophy in adult patients. The data are intended to strengthen…
    Endpoints · 1mo agoNeutral↗ source
  • HHS pushes FDA to formalize public release of rejection letters to drug makers
    HHS announced it is preparing a new FDA regulation that would codify the agency's practice of publishing complete response letters (CRLs) that inform pharmaceutical companies of a drug's rejection.…
    Endpoints · 1mo agoCRLNeutral↗ source
  • Biohaven targets muscle-sparing obesity market to compete with Lilly's GLP-1 drugs
    Biohaven is positioning itself to address obesity by developing treatments that preserve lean muscle, a differentiator from existing GLP-1 therapies. The company sees an opportunity to act as a "s…
    Endpoints · 1mo agoNeutral↗ source
  • Sanofi proposes to cease negative statements about CSL's flu vaccine amid EU probe
    Sanofi has offered to stop making disparaging comments about CSL's flu vaccine following an investigation launched by the European Commission. The offer comes two weeks after the Commission began p…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Vertex to acquire endocrinology startup Crinetics for $10 billion, signaling push into new therapeutic areas
    Vertex Pharmaceuticals announced a $10 billion cash purchase of Crinetics, an endocrinology-focused biotech. The deal represents the largest acquisition in Vertex’s history and underscores its pla…
    Endpoints · 1mo agoDealPositive↗ source
  • Vera Therapeutics receives accelerated approval for Trutakna to treat IgA nephropathy
    Vera Therapeutics announced that its fusion protein atacicept, branded as Trutakna, has been granted accelerated approval by the FDA for the treatment of immunoglobulin A nephropathy, a chronic aut…
    Endpoints · 1mo agoApprovalPositive↗ source
  • FDA grants accelerated approval to Vera Therapeutics' Trutakna for IgA nephropathy
    The FDA has granted accelerated approval to Trutakna (formerly known as atacicept) from Vera Therapeutics for adult patients with IgA nephropathy, a chronic kidney disease that can progress to rena…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Vertex to buy Crinetics for $10 billion, expanding into endocrine disease drugs
    Vertex announced an agreement to acquire Crinetics Pharmaceuticals for $10 billion in cash, paying $85 per share. The purchase brings two recently launched drugs for a rare hormonal disorder into…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • CMS launches ACCESS program to reward Medicare digital health solutions that improve outcomes
    The Centers for Medicare & Medicaid Services introduced the ACCESS program, a new initiative that invites digital health companies to participate in Medicare. The program ties Medicare payments to…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Oberland invests up to $400M in MeiraGTx eye gene‑therapy pipeline
    Oberland Capital Management announced a financing package that could total $400 million to support MeiraGTx's development of gene therapies for inherited eye disorders. The arrangement includes up…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Kailera's oral GLP-1 pill shows ~10% weight loss in Chinese Phase 3 trial
    Kailera Therapeutics reported that its oral GLP-1 candidate HRS-7535 achieved about 10% average weight loss over 44 weeks in a Phase 3 study in China. The highest daily dose led to a mean 9.8% red…
    BioPharma Dive · 1mo agoPositive readoutNeutral↗ source
  • Hengrui and Kailera's oral GLP-1 pill shows promising efficacy but notable side effects in Chinese obesity and diabetes trials
    Hengrui Pharma and Kailera Therapeutics reported results from two late‑stage trials in China, one targeting obesity and the other diabetes, using their daily oral GLP‑1 pill. The studies demonstrat…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Novartis, Vertex and Ipsen announce new acquisitions as M&A activity surges in early July 2026
    Biopharma’s merger and acquisition engine remains robust, with four companies revealing new deals within the first six days of July. The announcements add to a total of 45 acquisitions reported in…
    Endpoints · 1mo agoDealPositive↗ source
  • MeiraGTx secures $135 million royalty deal with Oberland Capital
    MeiraGTx announced a royalty financing agreement with Oberland Capital. The deal provides the gene-therapy company with an initial $135 million, including a $10 million equity investment from Oberl…
    Endpoints · 1mo agoDealPositive↗ 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