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  • FDA grants emergency use authorization for generic Bimectin injection to prevent screwworm in cattle
    The U.S. Food and Drug Administration announced an Emergency Use Authorization for the generic ivermectin product Bimectin injection, allowing its use to prevent New World screwworm infestations in…
    fda press · 2mo agoRegulatoryPositive↗ source
  • Long-term unemployment pushes many biopharma professionals to quit job searches
    A recent BioSpace LinkedIn poll shows that about one-quarter of biopharma workers who have been unemployed for six months or more have stopped looking for new positions, and a similar share are con…
    BioSpace · 2mo agoNegative↗ source
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  • Scaling delivery is key for CAR T therapies to succeed in autoimmune diseases
    Biopharma companies are exploring CAR T cell therapies as a potential cure for autoimmune disorders, a market that could be twice the size of oncology. While current treatments manage symptoms, the…
    BioSpace · 2mo agoNeutral↗ source
  • Generate Bio drops as data accidentally leaked ahead of European conference
    Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • FDA review highlights expanding role of manufacturing process models in drug applications
    The FDA released a review outlining how manufacturers can incorporate process modeling into their regulatory submissions. Process models are described as a growing scientific area and are being us…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Experts discuss hurdles and prospects for the first approved Fragile X therapy
    In a recent episode of BioSpace's "Denatured" podcast, Hilary Rosselot of the National Fragile X Foundation and Jordi Fàbrega, co‑founder and CEO of CONNECTA Therapeutics, talked about the current…
    BioSpace · 2mo agoNeutral↗ source
  • Biopharma hiring gaps: experts cite four key mismatches between companies and candidates
    Recruiting specialists highlighted persistent disconnects between biopharma employers and job seekers, noting that misaligned expectations can slow hiring and discourage talent. One major issue st…
    BioSpace · 2mo agoNeutral↗ source
  • MHRA revises guidance on periodic safety update reports for UK products
    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update to its pharmacovigilance procedures guidance. The revision focuses on the preparation and submission of periodic…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA considers new deputy commissioner roles as Trump prepares to announce additional MFN drug pricing agreements
    The Food and Drug Administration is evaluating the establishment of new deputy commissioner positions to support its expanding portfolio of responsibilities. The proposal reflects ongoing efforts…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA grants early approval to RevMed's pancreatic cancer drug Rasonque
    FDA granted early approval to Revolution Medicines' daraxonrasib, now named Rasonque, for pancreatic adenocarcinoma, arriving 6.5 months before the FDA deadline. The oral RAS inhibitor demonstrate…
    BioSpace · 2mo agoApprovalPositive↗ source
  • FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma. Rasonque is a tablet taken once daily that t…
    fda press · 2mo agoApprovalPositive↗ source
  • Summit Therapeutics and Akeso report Phase 3 survival benefit for ivonescimab in Chinese biliary tract cancer
    Summit Therapeutics and its Chinese partner Akeso said their bispecific antibody ivonescimab combined with chemotherapy improved overall survival for patients with first-line biliary tract cancer i…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • Jazz's Ziihera receives FDA approval for first-line treatment of HER2-positive gastroesophageal cancer
    The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals' bispecific antibody Ziihera for use as a first‑line therapy in patients with unresectable locally advanced or metastatic gas…
    BioSpace · 2mo agoApprovalPositive↗ source
  • Vitruvias Therapeutics shuts down after recalling potentially superpotent thyroid tablets
    Vitruvias Therapeutics announced it is ceasing operations and has voluntarily recalled a batch of its generic thyroid tablets because the product may be superpotent. The recall covers 3,655 units…
    BioSpace · 2mo agoCRLNegative↗ source
  • BMS terminates Cellares partnership after cell therapy platform fails to meet Breyanzi production needs, prompting layoffs
    Bristol Myers Squibb has ended its collaboration with manufacturing specialist Cellares after the Cell Shuttle system could not satisfy the requirements for producing the approved CAR‑T therapy Bre…
    BioSpace · 2mo agoDealNegative↗ source
  • Biohaven signs up to $795 million deal with SK Biopharma to license Kv7 platform and epilepsy asset
    Biohaven announced a licensing agreement with South Korean SK Biopharma centered on its Kv7 ion channel platform and lead epilepsy candidate opakalim. The deal could deliver up to $795 million, in…
    BioSpace · 2mo agoDealPositive↗ source
  • FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy review
    The FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • CDMO hiring struggles as demand for specialized talent outpaces supply
    Contract development and manufacturing organizations are finding it harder to fill positions, according to a search expert who tracks life-science talent. The surge in outsourcing has created a gap…
    BioSpace · 2mo agoNeutral↗ source
  • Inside the Gulf biotech deal model, ahead of RGMBS 2026 in Riyadh
    Sovereign capital, guaranteed offtake, and localization mandates are reshaping how biotech deals get structured in the Gulf, ahead of the Riyadh Global Medical Biotechnology Summit (RGMBS) 2026, 14…
    BioSpace · 2mo agoDealNeutral↗ source
  • FDA reportedly weighing two new deputy commissioner roles, one for health AI and one for drugs
    The Food and Drug Administration is said to be considering the creation of two additional deputy commissioner positions. The proposal is being reported by media outlets but has not been confirmed b…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • Industry groups call for clearer FDA guidance on QRIs in expedited IND pilot
    Pharmaceutical trade groups have voiced concerns about the FDA's proposed expedited IND pilot, which aims to speed entry of drug candidates into first‑in‑human studies. The groups say the FDA need…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Revival Animal Health recalls two feline milk replacer products over low vitamin and mineral levels
    Revival Animal Health of Orange City, Iowa announced a voluntary recall of its Breeder’s Edge and Shelter’s Choice feline milk replacers. Testing revealed the products contain lower than expected…
    fda recalls · 2mo agoCRLNegative↗ source
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 2mo agoApprovalPositive↗ source
  • Eli Lilly launches oral obesity drug Foundayo in the UK
    Eli Lilly has introduced its oral weight‑loss pill Foundayo to the United Kingdom market, positioning the small‑molecule therapy as a price‑sensitive alternative to injectable options. The UK Medi…
    BioSpace · 2mo agoRegulatoryPositive↗ source
  • Haisco partners with US VCs to launch immunology biotech Sentivera with up to $1.5B funding
    Haisco Pharmaceutical Group announced the creation of a new immunology-focused biotech called Sentivera, backed by two American venture‑capital firms, Population Health Partners and ARCH Venture Pa…
    BioSpace · 2mo agoDealPositive↗ source