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362 stories matching this filter · ← front page

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  • Can a chaotic FDA still deliver on faster drug development?
    As leadership changes create more instability at the FDA, here’s what one former agency official thinks it will take to keep speedier drug approvals on track.
    BioPharma Dive · 2mo ago↗ source
  • FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
    The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.
    fda press · 2mo ago↗ source
  • Pfizer, Innovent strike $10B cancer drug deal
    Involving up to 12 antibody drugs, the alliance is the latest broad partnership between Chinese biotech and a multinational pharmaceutical company.
    BioPharma Dive · 2mo ago
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fda recalls22
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Endocrinology & Metabolism290
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Infectious Disease253
Nephrology239
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  • GSK, Ionis unveil data for hepatitis B drug touted as ‘functional cure’
    The findings supporting bepirovirsen were deemed a “historic moment” by physicians and validate a drug that has “clear blockbuster potential,” according to one analyst.
    BioPharma Dive · 2mo ago↗ source
  • CVS obesity drug deal puts Lilly on equal footing with Novo
    The agreement includes Lilly’s new pill Foundayo and restores coverage for Zepbound, erasing what had been a commercial edge for rival Novo Nordisk.
    BioPharma Dive · 2mo ago↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 2mo ago↗ source
  • FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
    FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
    fda press · 2mo ago↗ source
  • BioMarin drug acquired in buyout misses goal in rare disease study
    Tested in a condition known as ENPP1 deficiency, the treatment failed a trial goal that’s important to regulators, spurring doubts about its approval prospects.
    BioPharma Dive · 2mo ago↗ source
  • A migraine drugmaker heads to the public markets through reverse merger
    Mentari Therapeutics, a spinout from the prolific hub-and-spoke biotech Paragon, is developing two medications it hopes can treat migraines that aren’t well controlled by existing drugs.
    BioPharma Dive · 2mo ago↗ source
  • Relay drug shows early promise against rare blood vessel diseases
    While early, the findings suggest the therapy could be superior to Novartis’ Vijoice at treating “vascular anomalies,” a cluster of chronic conditions with few available treatments.
    BioPharma Dive · 2mo ago↗ source
  • FDA approves AstraZeneca’s new kind of hypertension drug
    Baxfendy inhibits a blood-pressure-raising enzyme and, according to AstraZeneca executives, is poised to be a “big product” that should ultimately generate $5 billion or more in annual sales.
    BioPharma Dive · 2mo ago↗ source
  • Merck ADC, licensed from China, hits mark in first big global trial
    The endometrial cancer trial is the first of 17 late-stage studies Merck is running for a therapy that’s important to its ambitions of hitting $70 billion in annual sales next decade.
    BioPharma Dive · 2mo ago↗ source
  • Høeg fired in latest FDA shakeup; 20 people die after taking Amgen drug
    The agency has once again shuffled the leadership for two top drug review offices. Elsewhere, Parabilis partnered with Regeneron and an obesity pill is headed toward an approval in China.
    BioPharma Dive · 2mo ago↗ source
  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 2mo ago↗ source
  • Unlocking more value from mature drug products through strategic outsourcing
    See how strategic outsourcing can maximize value and reduce costs for mature drug portfolios.
    BioPharma Dive · 2mo ago↗ source
  • FDA hold puts Aardvark Prader-Willi drug in limbo
    The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its entire development program.
    BioPharma Dive · 2mo ago↗ source
  • Supreme Court preserves access to abortion pill by mail
    The ruling maintains access to the drug while litigation continues. Mifepristone can still be prescribed at pharmacies or by mail without requiring in-person visits.
    BioPharma Dive · 2mo ago↗ source
  • Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers
    Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted i…
    BioPharma Dive · 2mo ago↗ source
  • India’s pharma industry is going global. But can it catch up to China?
    A record Sun Pharma acquisition signals global ambitions. But infrastructure, capital and policy gaps could stand in the way of India becoming an R&D powerhouse.
    BioPharma Dive · 2mo ago↗ source
  • Create Medicines raises $122M to bolster in vivo CAR-T therapies
    The fresh funds will support the biotech's pipeline of RNA-based CAR-T cell therapies for cancer and autoimmune conditions.
    BioPharma Dive · 2mo ago↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 2mo ago↗ source
  • With new data, Regenxbio to seek FDA approval of Duchenne gene therapy
    Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”
    BioPharma Dive · 2mo ago↗ source
  • FDA’s leadership void leaves biotech with renewed ‘uncertainty’
    Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.
    BioPharma Dive · 2mo ago↗ source
  • Lilly data point to ‘maintenance’ strategies for GLP-1 weight loss
    A pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could help people with obesity keep their weight down over the long term.
    BioPharma Dive · 2mo ago↗ source
  • Assertio accepts new buyout bid; AI biotech Isomorphic banks $2B
    Assertio’s latest offer represents a roughly 31% premium over an initial acquisition proposal. Elsewhere, Kyverna is readying a first-of-its-kind approval application and AC Immune is swapping CEOs.
    BioPharma Dive · 2mo ago↗ source