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242 stories matching this filter · ← front page

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  • Beam Therapeutics' base-edited risto-cel shows 12-month pain-crisis freedom in sickle cell trial, paving way for FDA filing
    Beam Therapeutics reported that its base-edited cell therapy, risto-cel, achieved at least 12 consecutive months without severe vaso-occlusive crises in patients with sickle cell disease during a m…
    BioSpace · 5h agoPositive readoutPositive↗ source
  • Oura to buy AI health chatbot firm Counsel Health for $625 million
    Oura announced that it will acquire Counsel Health, a startup that builds clinical artificial‑intelligence tools, for a cash price of $625 million. Counsel Health operates a conversational chatbot…
    STAT · 4h agoDealPositive↗ source
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Nephrology759
  • FDA approves Bayer's Sunharbo, a new class drug to lower stroke recurrence
    The FDA has given its nod to a Bayer medication designed to cut the risk of another stroke in patients who have already suffered one. The product, marketed as Sunharbo, belongs to a newly created…
    STAT · 6h agoApprovalPositive↗ source
  • PepGen reports promising early results for myotonic dystrophy type 1 drug in six-patient trial
    PepGen announced that its experimental therapy for myotonic dystrophy type 1 showed the most encouraging early data yet in a small study. The trial involved six patients who received the drug for 1…
    STAT · 9h agoPositive readoutPositive↗ source
  • Amneal and BridgeBio top BioSpace 2027 Best Places to Work list
    BioSpace released its 2027 Best Places to Work list, recognizing 50 life‑science employers with U.S. operations. Amneal Pharmaceuticals, based in Bridgewater, New Jersey, took the top spot among l…
    BioSpace · 16h agoPositive↗ source
  • STAT+: GLP-1s are given an FDA warning for rare eye condition risk
    The FDA warned that GLP-1 drugs carry a potential risk of a rare but serious eye condition sometimes referred to as an “eye stroke.”
    STAT · 6h ago↗ source
  • FDA approves Bayer’s Sunharbo, first Factor XIa inhibitor to lower stroke recurrence risk
    The Food and Drug Administration has approved Bayer's new medication intended to prevent another stroke in patients who have already experienced one. The drug, sold under the brand name Sunharbo,…
    STAT · 22h agoApprovalPositive↗ source
  • FDA warns GLP-1 weight-loss drugs may cause rare eye stroke condition
    The Food and Drug Administration issued a warning that GLP-1 drugs used for weight loss may be linked to a rare eye condition called non-arteritic anterior ischemic optic neuropathy, sometimes desc…
    STAT · 1d agoRegulatoryNegative↗ source
  • FDA mandates label update for all GLP-1 drugs to warn of rare eye disease risk
    The FDA issued a class‑wide labeling requirement for all approved GLP‑1 receptor agonists, adding a warning about non‑arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • FDA requires GLP-1 drug labels to include warning about rare eye disease
    The FDA has issued a directive to manufacturers of GLP-1 therapies, instructing them to revise product labeling. The label change must highlight an increased risk of a rare ocular condition that c…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • American Heart Association meeting reports neutral outcomes for inflammation and Lp(a) trials
    The American Heart Association's scientific sessions in Chicago highlighted a theme of neutral findings across cardiovascular research. Two high profile trials, ZEUS targeting inflammation and HOR…
    STAT · 1d agoNeutral↗ source
  • AI chatbots may help men share emotions, study suggests
    AI chatbots are not therapists, but they can offer a low‑pressure space where men feel less judged when discussing personal concerns. The article follows Luca, who drove across Europe to be with h…
    STAT · 1d agoNeutral↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
  • Newly elected scientists aim to restore health equity programs cut by Trump administration
    Two newly elected officials with scientific credentials, Michigan Senator-elect Abdul El-Sayed, an epidemiologist, and Georgia Rep-elect Jasmine Clark, a microbiologist, are preparing to join Congr…
    STAT · 3d agoPositive↗ source
  • Forge Biologics VP sees AI and Ohio talent driving next wave of gene therapy manufacturing
    Samantha Piteri-Molina, vice president of business and strategy at Forge Biologics, said her focus is on getting gene therapies into patients' hands. She helped steer Forge through a $620 million…
    BioSpace · 4d agoPositive↗ source
  • Kratom use rises as health officials warn of addiction risk and push emergency bans
    Kratom, a plant‑derived supplement, is becoming more visible in smoke shops and gas stations, yet most Americans remain unfamiliar with the product. Health officials have highlighted the addiction…
    STAT · 4d agoRegulatoryNegative↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 4d agoApprovalPositive↗ source
  • RevMed's pancreatic cancer drug Rasonque generates $198M in Q3, far exceeding forecasts
    RevMed reported $198 million in revenue from its newly launched pancreatic cancer therapy Rasonque during the third quarter, roughly ten times the $19 million estimate from Truist Securities. The…
    BioSpace · 5d agoPositive readoutPositive↗ source
  • Revolution Medicines' Rasonque generates $198 million in sales within five weeks of U.S. approval
    Revolution Medicines reported that its pancreatic cancer therapy Rasonque has achieved $198 million in revenue in the first five weeks after receiving U.S. approval. The company said more than 5,00…
    STAT · 5d agoApprovalPositive↗ source
  • New treatments for preeclampsia move closer to patients
    Emily Chaddock’s experience highlights the danger of severe preeclampsia, a pregnancy complication that can threaten both mother and baby. At 27 weeks she developed the condition, leading to a rapi…
    Endpoints · 5d agoPositive↗ source
  • Democrats win Congress and doctors secure key seats, shifting health policy direction
    The recent midterm elections gave Democrats control of both the House and the Senate. Voters also elected a number of doctors and scientists to key congressional positions. These outcomes signal a…
    STAT · 6d agoRegulatoryPositive↗ source
  • Minghui Pharma sells Japanese rights to its Phase 3 thyroid eye disease drug for $110 million upfront
    Minghui Pharmaceutical, a Shanghai‑based biotech, has agreed to transfer the Japanese commercial rights for its late‑stage thyroid eye disease candidate to a specialty pharmaceutical company. The…
    Endpoints · 6d agoDealPositive↗ source
  • Spyre Therapeutics reports SPY072 fails psoriatic arthritis trial as Ideaya halts eye cancer study
    Spyre Therapeutics announced that its long‑acting anti‑TL1A candidate, SPY072, did not meet the primary endpoints in a psoriatic arthritis trial. The result adds to recent setbacks for Spyre in ot…
    Endpoints · 6d agoNegative readoutNegative↗ source
  • Flagship partner Louisa Helms credits high-school librarian for sparking biotech career
    Louisa Helms, a BioSpace 40 Under 40 honoree and partner at Flagship Pioneering, reflects on a unique path into biotech. In high school she was mentored by librarian Tammy Carabello, who turned th…
    BioSpace · 6d agoPositive↗ source
  • American expatriate in Malta finds free health care but misses digital patient portal
    Mariska Breland, an American co‑founder of The Neuro Studio, moved to Malta seeking free health care and recounts her first visit to a local general practitioner. She describes a modest clinic wit…
    STAT · 6d agoNeutral↗ source