A doctor recommended Grail's Galleri cancer blood test, but recent UK trial of 142,000 people showed it failed to reduce late-stage cancers despite early promise and $949 price tag.

US clinical trials, particularly in oncology, have become increasingly redundant, inefficient and expensive. And the growing costs come just as China’s biotech industry has blossomed.

Summit Therapeutics is running late-stage trials for biopharma’s buzziest drug in lung cancer, but some industry experts believe ivonescimab and other PD-1xVEGF bispecifics may better target another t...

Startup Excellergy debuts with $70M Series A to develop drugs targeting allergic diseases, aiming to compete with Roche/Novartis' Xolair through new immune response approach.

FDA approves Keytruda Qlex, Merck's new subcutaneous formulation of Keytruda, offering more convenient administration and patent protection through 2039.

Biotechs and their investors have long called for lower interest rates since the pandemic’s free-flowing fundraising environment dried up a few years ago. But there are other challenges facing the industry.

As Wall Street continues to digest this week’s disappointing results for Summit Therapeutics’ PD-1xVEGF bispecific cancer drug, Pfizer is primed to take advantage.

Summit Therapeutics is facing fresh scrutiny after mixed Phase 3 trial results for its cancer drug ivonescimab, leading to a 25% stock drop and questions about FDA approval.

NRG Therapeutics announced the close of a £50 million Series B round that should take it through a Phase 2 study in ALS and a Phase 1b trial in Parkinson’s.

Summit Therapeutics released a much-anticipated cut of ivonescimab data in North American and European lung cancer patients on Sunday,

The FDA approved a new formulation of Eisai and Biogen’s Alzheimer’s drug Leqembi, an incremental step in the companies’ strategy to compete with Eli Lilly’s Kisunla.

A recent label expansion is sending sales of Alnylam’s Amvuttra through the roof. The drug pulled in $492.0 million in revenue in the second quarter, up 114% from the ...

FDA's CBER head Vinay Prasad exits agency after Sarepta gene therapy controversy and criticism over Covid vaccine decisions. Conservative media targeted his political views.

Celcuity reports gedatolisib with fulvestrant reduced disease progression risk by 67% vs fulvestrant alone in Phase 3 breast cancer trial

FDA panel on antidepressant use in pregnancy features experts known for opposing medical consensus, includes discussion with Commissioner Marty Makary on Monday.

John Houston is planning to retire at Arvinas after more than eight years at the helm, the company announced Wednesday, as its lead protein degrader program approaches an inflection point.

On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.).

Welcome to the fourth edition of Endpoints News’ special report on scientists, executives, investors and other stakeholders in the biopharma’s LGBTQ+ community.

CHICAGO — Gilead and Merck made a strong case for combining Trodelvy and Keytruda in the first-line setting for an aggressive form of breast cancer. The combination of Trodelvy and Keytruda ...

Summit Therapeutics’ mixed results for its potential competitor to Merck’s Keytruda left an important question unanswered: How mature, exactly, were the data?

The Cubs' Marquee Sports Network, citing ABC News, said the new pontiff supports the North Siders. But his brother said that is not true.

How did biopharma stocks react to Vinay Prasad’s appointment as director of one of the FDA's top jobs? Not well. Prasad, a hematologist-oncologist by training who gained prominence for criticizing ...

Bristol Myers Squibb’s attempt to turn Cobenfy into a megablockbuster neuroscience drug ran into a stumbling block Tuesday afternoon.

The Johnson & Johnson CEO subtly but assertively criticized the Trump administration’s plans for pharmaceutical tariffs, saying they are not an effective tool to onshore drug manufacturing to the US.

Tariffs on pharmaceutical products that President Donald Trump has teased for weeks are one step closer to fruition after the Department of Commerce confirmed it's launched an investigation into the s...

Under the 11-page 'roadmap' outlined Thursday, the goal is for alternative methods to become 'the exception rather than the norm' in the next three to five years.

The fallout comes amid a yearslong slog for biotech, which has struggled since high interest rates and inflation curbed what was a booming market during the Covid-19 pandemic.

FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.

FDA biologics chief Peter Marks resigns over vaccine dispute with HHS Secretary RFK Jr., causing biotech stocks to drop. Moderna down 11%, Sarepta down 7.5%, uniQure down 20%.

Alpha Lee announced a Zika virus-fighting molecule at a chemistry meeting, but later learned his $67M federal funding was cut due to pandemic's end, affecting multiple antiviral research programs.

FDA approves Sanofi's RNAi hemophilia drug fitusiran, licensed from Alnylam, to treat both hemophilia A and B by lowering antithrombin protein levels.

FDA approves Soleno Therapeutics' diazoxide choline (DCCR) to treat hyperphagia in Prader-Willi syndrome patients, marking first approved treatment for the rare disease.

Actinium Pharmaceuticals holds investor event at Trump's Mar-a-Lago resort, discussing Actimab-A and Iomab-ACT programs. CEO Sandesh Seth announces

Alnylam will likely face challenges in turning a profit this year, despite executives promising to do so. But the label for its newly-approved Amvuttra indication may give it an advantage over its riv...

Alnylam's future profitability hinges on the ability to get Amvuttra prescribed as a first-line option in ATTR-CM, which is an increasingly competitive market led by Pfizer’s Vyndaqel/Vyndamax franchi...

A teenage boy who received Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys died from liver failure, the biotech said Tuesday morning.

A visit with a family in mourning

A UK startup that wants to bring protein degraders to the neurodegeneration field has closed a $31 million seed round.

A child has died in an outbreak that has grown to 146 cases.

For the fourth year running, Endpoints News will highlight the biotech leaders who are paving the way for the LGBTQ+ community. Nominations are now open via this form for the 2025 LGBTQ+ Leaders in Bi...

Something changed for Bill Anderson when he turned 50. He was ascending the ranks of Roche’s Genentech, but the Texas native felt like he was stuck in the same loop ...

How much weight loss is too much? Pharma is pushing the limit with new obesity drugs.

BridgeBio revealed Thursday that prescriptions for its recently approved rare heart disease drug Attruby substantially beat analyst projections — an update that is likely to further boost confidence i...

On a sunny September day in 2023, scientists at CRISPR Therapeutics invited me to peer through their microscopes. Through the lens were liver cells, part of the company’s work to gear up for a clinica...