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309 stories matching this filter · ← front page

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  • FDA’s radical transparency policy for rejections runs into legal uncertainty
    Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
    BioSpace · 10d ago↗ source
  • 2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq
    Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the pandemic-driven high of 2021.
    BioSpace · 10d ago↗ source
  • Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
    The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for…
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Dermatology51
BioSpace · 10d ago
↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 10d ago↗ source
  • How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
    Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
    BioSpace · 10d ago↗ source
  • Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 10d ago↗ source
  • Asia-Pacific Roundup: TGA seeks feedback on Australian regulations for digital mental health tools
    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).
    raps · 10d ago↗ source
  • Study: China outpaces the US in cancer approvals, lags behind on first approvals
    While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more fi…
    raps · 10d ago↗ source
  • MHRA touts uptick in approvals in 2025-2026 annual report
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs tha…
    raps · 10d ago↗ source
  • Relay Peak Research LLC Recalls Zen Principle® Moringa Capsules Because of Possible Health Risk
    Relay Peak Research LLC (Zen Principle Naturals) of Incline Village, NV is voluntarily recalling its Zen Principle® brand Moringa Capsules dietary supplement because the product has the potential t…
    fda recalls · 10d ago↗ source
  • Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine
    FOR IMMEDIATE RELEASE – July 18th, 2026 – Panoli, Gujarat, Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling four lots of Cetirizine Hyd…
    fda recalls · 12d ago↗ source
  • Fayus Inc., dba Yusol International Foods Expands Recall of OLA-OLA POUNDED YAM Due to Undeclared Milk Allergen
    Fayus Inc., doing business as Yusol International Foods (Sacramento, CA) is expanding its recall of OLA-OLA POUNDED YAM to include product sizes 2lbs, 4lbs, 5lbs, and 10lbs due to product labeling…
    fda recalls · 12d ago↗ source
  • India’s life sciences sector at turning point for innovation: Report
    Structural gaps in areas including clinical execution and funding limit India’s ability to scale up innovation, according to a report from Boston Consulting Group and HealthKois.
    BioSpace · 13d ago↗ source
  • GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
    Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
    BioSpace · 13d ago↗ source
  • Insmed moves closer to $6B opportunity as PAH drug shows long-term durability
    Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements thro…
    BioSpace · 13d ago↗ source
  • FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking
    Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…
    BioSpace · 13d ago↗ source
  • Taylor Fresh Foods Recalls Iceberg Lettuce from Central Mexico Because of Possible Health Risk
    Taylor Farms de Mexico of Guanajuato, Mexico is voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market, because it has the potential to be contaminated with Cyclo…
    fda recalls · 13d ago↗ source
  • Experts: Ending adequate provision would shut down prescription drug ads
    The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the hig…
    raps · 13d ago↗ source
  • Industry wants more clarity on NGS for assessing gene therapy safety
    The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. Ho…
    raps · 13d ago↗ source
  • This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This wee…
    raps · 13d ago↗ source
  • Khong Guan Corporation Issues Recall of Glutinous Rice Balls With Black Sesame Filling Due to Undeclared Peanuts
    Khong Guan Corporation is recalling specific lots of “Glutinous Rice Balls with Black Sesame Filling” because they may contain undeclared peanuts. People who have an allergy or severe sensitivity t…
    fda recalls · 14d ago↗ source
  • FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers
    The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversigh…
    BioSpace · 14d ago↗ source
  • Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover
    With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry.
    BioSpace · 14d ago↗ source
  • Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor
    Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.
    BioSpace · 14d ago↗ source
  • Braveheart, Attovia, Vogenx keep IPOs ballooning with plans to compete in cardiometabolic, immuno
    Braveheart Bio is looking to take on Bristol Myers Squibb in hypertrophic cardiomyopathy, while Attovia Therapeutics wants to challenge Sanofi and Regeneron’s Dupixent. Vogenx, meanwhile, is lookin…
    BioSpace · 14d ago↗ source