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27 stories matching this filter · ← front page

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  • Heidi Overton nominated as FDA commissioner, seen as boost for psychedelics and non-opioid pain drugs
    President Donald Trump announced that he will nominate Heidi Overton, a current White House policy advisor, to serve as the next FDA commissioner pending Senate confirmation. Analysts say Overton’…
    BioSpace · 22h agoRegulatoryNeutral↗ source
  • Biopharma hiring surges in New Jersey, 11 companies post dozens of new roles
    BioSpace data shows job postings for biopharma positions in New Jersey have risen year over year, with a notable 73% jump in July compared with the same month last year. The upward trend has persi…
    BioSpace · 1d agoPositive↗ source
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fda recalls47
fda medwatch37
fda press28
899
Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism380
Pain373
Infectious Disease353
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • LEO Pharma spends $435 million to acquire rare-disease skin drug dersimelagon
    LEO Pharma announced it will pay $435 million to buy the rights to dersimelagon, an oral MC1R agonist originally developed by Tanabe Pharma. The drug has completed Phase 3 trials for two rare phot…
    BioSpace · 2d agoDealPositive↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial after safety concerns
    Regeneron announced termination of a Phase 1/2 study of its investigational anti-inflammatory antibody REGN7041, which was being evaluated for non-infectious uveitis. The company said the decision…
    BioSpace · 2d agoNegative↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial over unfavorable risk-benefit profile
    Regeneron has stopped a Phase 1/2 study of its anti‑inflammatory antibody REGN7041 in non‑infectious uveitis, citing an unfavorable benefit‑risk assessment. The antibody targets CD3 on immune cell…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Leo Pharma to license Tanabe’s oral drug for rare light-sensitive skin disease, paying up to $435 million
    Leo Pharma announced a licensing agreement with Japan's Tanabe Pharma for an oral treatment targeting two genetic skin disorders that cause pain when exposed to sunlight. Under the deal, Leo Pharm…
    Endpoints · 2d agoDealNeutral↗ source
  • Bankrupt Sangamo sells Fabry gene therapy to PTC and prion program to Lilly for $161M
    Sangamo Therapeutics, currently in Chapter 11 bankruptcy, has agreed to divest its Fabry disease gene therapy and several other platforms to raise cash for the restructuring. PTC Therapeutics emer…
    BioSpace · 7d agoDealNeutral↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 10d agoDealNeutral↗ source
  • BlossomHill and Latigo close IPO week with $496 million raised
    BlossomHill Therapeutics, a cancer‑focused biotech, completed its initial public offering this week. Latigo, a company developing non‑opioid pain treatments, also went public at the same time. To…
    Endpoints · 13d agoDealPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 13d agoApprovalPositive↗ source
  • Braveheart Bio targets $382 million IPO to fund cardiac drug development
    Braveheart Bio announced an upsized initial public offering on the Nasdaq, aiming to raise about $382.5 million. The company will sell 21.2 million shares at $18 each under the ticker BRVE. The pr…
    BioSpace · 14d agoDealPositive↗ source
  • Eli Lilly posts $23 B Q2 revenue, beats forecasts as Foundayo lags behind Novo's oral GLP-1
    Eli Lilly reported second‑quarter revenue of $23 billion, a 48% increase from the prior year and well above analysts' expectations. The strong top‑line helped the company deliver a sizable earnings…
    BioSpace · 15d agoEarningsNeutral↗ source
  • Lilly and FDA clash over retatrutide classification as company nears submission
    Eli Lilly is preparing to file its obesity drug candidate retatrutide for approval while a legal dispute with the FDA over the drug's classification intensifies. The agency has concluded that reta…
    BioSpace · 15d agoRegulatoryNeutral↗ source
  • Latigo Biotherapeutics reports non-opioid drug cuts acute pain in Phase 2b trial
    Latigo Biotherapeutics announced that its experimental non-opioid analgesic demonstrated a reduction in acute pain in a Phase 2b clinical trial. The study results suggest the candidate may offer a…
    Endpoints · 20d agoPositive readoutPositive↗ source
  • OKYO Pharma CSO Raj Patil boosts stake to 20,030 shares
    OKYO Pharma, a clinical stage biotech focused on neuropathic corneal pain and anterior segment eye diseases, disclosed that its chief scientific officer, Raj Patil, PhD, bought additional shares.…
    globenewswire health · 23d agoDealNeutral↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 24d agoRegulatoryNeutral↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 27d agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 27d agoRegulatoryNeutral↗ source
  • FDA’s 505(b)(2) pathway offers faster, cheaper drug development and commercial gains
    The FDA’s 505(b)(2) regulatory route lets drug sponsors build on existing safety and efficacy data while proposing meaningful changes to a known product. By leveraging prior findings, companies can…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • BlossomHill and Latigo lead a surge of biotech IPOs after summer dry spell
    After a seven‑month lull that left no biotech companies on the public markets last summer, the sector is seeing renewed activity. BlossomHill Therapeutics and Latigo have filed to list on Nasdaq,…
    Endpoints · 1mo agoDealPositive↗ 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
  • FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
    The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…
    fda press · 1mo ago↗ source
  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 1mo ago↗ source
  • Lilly buys another pain biotech; FDA sets decision for once-weekly PrEP pill
    Plus, news about Merck, MultiValent Biotherapies, Alvotech, enGene, Mirum, and Adaptive Biotechnologies. 💸 Eli Lilly acquires another pain biotech: The Indianapolis pharma giant has made its 11th…
    Endpoints · 2mo ago↗ source