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1,995 stories matching this filter · ← front page

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  • Lilly and Boehringer cut German investments amid health-spending overhaul
    A proposed overhaul of Germany's health-insurance financing is sparking criticism from industry groups. Eli Lilly and Boehringer Ingelheim announced they will reduce their investment programmes in…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Supreme Court unanimously backs Hikma's skinny label fish oil generic
    The U.S. Supreme Court issued a unanimous decision favoring Hikma Pharmaceuticals in a dispute over its skinny label version of a prescription-strength fish oil product. The court ruled that Hikma…
    Endpoints · 3mo agoRegulatoryPositive↗ source
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  • Parabilis Medicines targets over $400 million in Nasdaq IPO to fund peptide pipeline
    Parabilis Medicines, a peptide-focused biotech led by former Johnson & Johnson R&D head Mathai Mammen, announced plans for a Nasdaq initial public offering. The company aims to raise more than $40…
    Endpoints · 3mo agoDealPositive↗ source
  • ADC Therapeutics' Zynlonta confirmatory trial shows higher death rates, clouding full approval prospects
    ADC Therapeutics is pursuing full FDA approval for its antibody-drug conjugate Zynlonta in patients with relapsed or refractory diffuse large B-cell lymphoma. In the confirmatory study presented,…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • ADC biotech Ona Therapeutics raises $86.6M in Series B to move two ADC candidates toward clinic
    Barcelona-based Ona Therapeutics announced a $86.6 million Series B financing round. The capital will be used to move two antibody‑drug conjugate (ADC) programs into early‑stage clinical testing.…
    Endpoints · 3mo agoDealPositive↗ source
  • Spanish biotech Ona Therapeutics secures $86.6 million Series B to advance new ADCs for breast and colorectal cancer
    Ona Therapeutics, a Barcelona‑based biotechnology startup, announced a Series B financing round that raised roughly $86.6 million. The new capital will fund the launch of two antibody‑drug conjuga…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Acting FDA Commissioner Kyle Diamantas says he will not seek permanent appointment
    Acting FDA Commissioner Kyle Diamantas has indicated that he does not intend to remain in the role on a permanent basis. Sources close to the administration say that the search for a new permanent…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Acting FDA chief vows to shield rare-disease discussions from political influence
    Acting FDA Commissioner Kyle Diamantas met with executives from fifteen rare‑disease nonprofit groups and senior agency staff. During the gathering he emphasized a new approach that differs from th…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Elevance Health’s chief digital officer discusses practical AI applications for insurers
    Elevance Health interviewed its chief digital information officer, Ratnakar Lavu, about how health insurers are adopting artificial intelligence. Lavu, who previously held digital roles at Kohl’s,…
    Endpoints · 3mo agoNeutral↗ source
  • Axsome secures settlement to keep Sunosi exclusive until 2040
    Axsome Therapeutics announced it has reached a settlement that pushes back the entry of generic versions of its narcolepsy medication Sunosi until 2040. The agreement was reached with the last rem…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Bipartisan House bill would require security review of U.S. biotech investments in China
    A bipartisan group of Representatives introduced legislation on Tuesday that would expand the Committee on Investment and National Security (COINS) Act to cover biotechnology. The bill, called the…
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Eli Lilly partners with Ascidian Therapeutics on $1.9 b RNA exon-editing collaboration for kidney disease
    Eli Lilly and Boston-based Ascidian Therapeutics announced a research collaboration aimed at discovering medicines for genetically driven kidney diseases. The partnership leverages Ascidian’s RNA e…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • NewLimit raises $435M Series C to launch epigenetic anti-aging therapy, while Lilly signs GLP-2 obesity drug deal
    Longevity startup NewLimit announced a $435 million Series C financing, one of the largest biotech rounds this year. The round was led by Founders Fund and included investors such as Thrive Capital…
    BioPharma Dive · 3mo agoNeutral↗ source
  • Regeneron expands partnership with CytomX as other pharma partners exit
    Regeneron announced it will deepen its collaboration with CytomX Therapeutics, a Bay Area biotech. The decision follows CytomX losing several partnership agreements with other large pharmaceutical…
    Endpoints · 3mo agoDealPositive↗ source
  • Eli Lilly signs up to $1.9B deal with Ascidian Therapeutics for RNA editing in kidney disease
    Ascidian Therapeutics recently presented early data indicating that its novel RNA‑editing approach to repair faulty genes appears safe in humans, focusing on kidney disease applications. Eli Lilly…
    Endpoints · 3mo agoDealPositive↗ source
  • Alnylam commits $30 million upfront to AI startup Inceptive for RNA research collaboration
    Alnylam Pharmaceuticals announced a new collaboration with Inceptive, a Silicon Valley biotech startup that focuses on RNA. The agreement includes an upfront payment of $30 million and is intended…
    Endpoints · 3mo agoDealPositive↗ source
  • Eli Lilly says its GLP-1 weight loss shot and pill now covered for millions of Americans
    Eli Lilly announced that its GLP-1 based weight-loss injection and oral medication have been added to the formularies of the three largest pharmacy benefit managers. The company said this move make…
    Endpoints · 3mo agoPositive↗ source
  • Mineralys Therapeutics raises funds ahead of pending lorundrostat hypertension approval
    Mineralys Therapeutics first came to market attention in 2021 when it licensed a novel hypertension candidate, lorundrostat, from Japan’s Tanabe Pharma, agreeing to a modest $1 million upfront paym…
    Endpoints · 3mo agoDealNeutral↗ source
  • FDA issues new guidance for pharma on discussing unapproved drugs with payors
    The FDA has released guidance aimed at biopharma companies that are preparing to launch new therapies before they receive formal approval. The advice focuses on how companies can inform health-pla…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Legend surges on early data for ‘in vivo’ lymphoma cell therapy
    Initial findings show that the therapy reduced or eliminated disease signs in all recipients, sparking hopes that the treatment might be competitive with “ex vivo” medicines like Novartis’ Kymriah.
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Bristol Myers Squibb assesses AI spending after deploying tools to thousands of staff
    Bristol Myers Squibb has recently provided artificial intelligence applications to a large portion of its workforce. The company is now turning its attention to measuring the cost of these tools a…
    Endpoints · 3mo agoNeutral↗ source
  • Roche reports narrow failure of breast cancer pill in Phase 3 trial at ASCO
    Roche updated investors and the oncology community that its experimental breast cancer oral therapy did not meet its primary endpoint in a pivotal Phase 3 study. The data, presented at the America…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Fulcrum Therapeutics considers sale after FDA blocks sickle cell drug development
    Fulcrum Therapeutics announced it is undertaking a strategic review that could lead to a sale after its lead sickle cell candidate, pociredir, was effectively blocked by the FDA. The agency cited…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • AbiVax shares plunge as safety concerns shadow strong ulcerative colitis trial results
    AbiVax reported Phase 3 data for its experimental therapy obefazimod in patients with moderately to severely active ulcerative colitis. Two dose levels achieved placebo‑adjusted clinical remission…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source