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2,276 stories matching this filter · ← front page

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  • FDA clears Aptitude’s latest Metrix molecular dx to test for COVID
    The FDA granted Aptitude its first 510(k) clearance for the next-generation Metrix COVID diagnostic that features three-times greater sensitivity with 30% faster results that its original emergency…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • FDA approves Eli Lilly's oral SERD Inluriyo combo for second-line metastatic breast cancer
    The FDA has given approval to a new combination therapy from Eli Lilly that includes its oral selective estrogen receptor degrader, Inluriyo, for patients with metastatic breast cancer who have pro…
    Endpoints · 1mo agoApprovalPositive↗ source
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  • EU regulator backs Novo's hemophilia A preventive therapy and recommends seven additional drugs
    The European Medicines Agency's human medicines committee issued a positive opinion on Novo's preventive treatment for hemophilia A, indicating it meets the agency's standards for further developme…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Novo Nordisk acquires three early-stage obesity programs from Kallyope
    Novo Nordisk announced the purchase of three early-stage obesity drug programs from New York‑based biotech Kallyope, expanding its metabolic pipeline. The acquired assets are not GLP‑1 incretins.…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Electra Therapeutics raises $350 million in Nasdaq IPO to fund commercial expansion
    Electra Therapeutics announced that it priced its initial public offering on the Nasdaq at $350 million, becoming the 21st biotech to go public in 2026. The Bay Area‑based company said the capital…
    Endpoints · 1mo agoDealPositive↗ source
  • All 50 states, DC, and Puerto Rico join new Medicaid most-favored-nation drug pricing model, Trump says
    President Donald Trump announced that every U.S. state, the District of Columbia and Puerto Rico will take part in a new Medicaid drug‑pricing framework. The model requires pharmaceutical manufact…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA reports decline in initial drug rejections, refutes claims of rising denials
    The U.S. Food and Drug Administration announced that the number of drugs turned down after an initial review has fallen, contrary to recent speculation. The agency said the notion that it is incre…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • China unveils new five-year plan to boost biotech and pharma and compete globally
    China's government released its latest five-year plan aimed at expanding the country's biotech and pharmaceutical sectors. The document outlines a strategy to strengthen research, development and m…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Alkermes reports promising Phase 1b results for orexin agonist ALKS 7290 in ADHD
    Alkermes presented data from a Phase 1b study that evaluated its orexin-based compound ALKS 7290 in adults with attention-deficit/hyperactivity disorder. The trial enrolled 50 participants who rece…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • AI's early, uneven impact on clinical trials sparks surprise
    The pharmaceutical industry is beginning to see artificial intelligence applied to clinical trial processes, though adoption is occurring in fits and starts. Early uses of AI are emerging in areas…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Medtronic secures FDA clearance for LigaSure vessel sealer on Hugo robotic platform
    Medtronic announced that the U.S. Food and Drug Administration has cleared its LigaSure RAS Maryland jaw vessel sealer-divider for use with the company's Hugo robotic-assisted surgery system. The…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Xenon pauses enrollment in phase 3 depression trials after reports of psychosis and other neuropsychiatric events
    Xenon Pharmaceuticals announced it has voluntarily stopped enrolling new patients in its two phase 3 studies of azetukalner for major depressive disorder and bipolar depression. The decision follo…
    Fierce Biotech · 1mo agoNegative↗ source
  • BMS abandons $100 million Orum degrader-antibody conjugate after early phase-1 results
    Bristol Myers Squibb has decided to stop development of the degrader‑antibody conjugate it purchased from Orum Therapeutics for $100 million after reviewing data from a phase‑1 trial. The experime…
    Fierce Biotech · 1mo agoDealNegative↗ source
  • Electra Therapeutics raises $350 million in oversubscribed IPO
    Electra Therapeutics, a South San Francisco biotech focused on inflammation, completed its Nasdaq IPO, selling 23.3 million shares at $15 each and generating $350 million in gross proceeds. This a…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Legend Biotech appoints former Novartis exec Ingrid Zhang as CEO amid falling share price
    Legend Biotech announced the appointment of Ingrid Zhang, a former Novartis executive, as its new chief executive officer. The leadership change comes as the company faces growing competition for…
    Endpoints · 1mo agoNeutral↗ source
  • Biopharma prediction markets raise insider-info concerns, regulators weigh oversight
    Prediction markets are emerging as platforms where participants can wager on biopharma events such as clinical trial results and FDA approvals. The format allows crowds to aggregate expectations ab…
    Fierce Biotech · 1mo agoNeutral↗ source
  • FDA faces nominee hearing, hiring woes and reviews of psychedelics and testosterone therapies
    A Senate committee set a hearing for President Trump's pick to lead the FDA, highlighting the political scrutiny of the agency's top leadership. New reporting reveals ongoing hiring challenges at…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Anthropic opens limited access to Mythos AI for life-science researchers
    Anthropic announced it is beginning a verification program that will let a select group of life-science researchers use its Mythos large-language model. When Mythos was first released on July 1, t…
    Endpoints · 1mo agoPositive↗ source
  • Artelo’s oral cannabinoid agonist matches semaglutide weight loss in obese mice, doubles effect when combined
    Artelo Biosciences reported that its oral dual cannabinoid agonist, ART27.13, produced weight loss in diet‑induced obese mice that was comparable to the GLP‑1 receptor agonist semaglutide. In a fo…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • China biotech policy debate moves to Washington for live discussion
    Endpoints News brought its ongoing China biotech debate to the nation’s capital, arranging a live session with officials shaping upcoming regulations. The event featured interviews with several po…
    Endpoints · 1mo agoNeutral↗ source
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known…
    fda press · 1mo agoApprovalPositive↗ source
  • Roche's Lunsumio clears Phase 3 hurdle, paving way for broader label in indolent lymphoma
    Roche announced that its T cell engager Lunsumio successfully met the primary endpoints in a Phase 3 study of a slow growing blood cancer. The trial, conducted in patients with indolent lymphoma,…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Clinical trial enrollment crisis threatens billions in revenue and patient access
    Clinical trials are struggling with enrollment, with about 80% missing timelines and less than 5% of eligible adult cancer patients participating. Delays have huge financial impact; each day a pha…
    Fierce Biotech · 1mo agoNegative↗ source
  • Orbis Medicines signs up to $1.4 billion partnership with Novo to develop macrocycle drugs for cardiometabolic disease
    Orbis Medicines, which is backed by Eli Lilly, announced a new collaboration with Novo focused on drug discovery. The agreement, valued at up to $1.4 billion, will target the creation of macrocycl…
    Endpoints · 1mo agoDealNeutral↗ source
  • Roche inks $1 billion deal with Dualitas to screen 300,000 bispecific combos for immunology and inflammation
    Roche has agreed to pay Dualitas Therapeutics an upfront $36.5 million as part of a broader agreement that could be worth up to $1 billion. The collaboration will use Dualitas’s DualScreen platfor…
    Fierce Biotech · 1mo agoDealPositive↗ source