Robuta

The company is planning a “broad Phase 3 program” for two anticoagulants after they outperformed marketed medicines in a pair of mid-stage trials.

Givosiran, which will be sold as Givlaari, is the second RNAi therapeutic cleared by the agency after Alnylam's Onpattro.

The biotech is working on a dual-acting weight loss treatment that could compete with medicines from Novo Nordisk, Eli Lilly and others.

The approval could help Rybelsus compete with oral drugs marketed by Eli Lilly, Merck & Co. and others.

Lilly’s decision comes as the FDA has indicated potentially higher approval standards for drugs meant to preserve muscle in people taking weight loss...

The agency’s decision also converts the biologic drug's approval from accelerated to full, confirming an earlier OK based on tumor responses.

European authorities cleared Gilead’s long-acting shot for patients whose HIV infection is resistant to other drugs. An FDA decision is expected by December.

The stem cell therapy company said the restructuring is meant as a first step toward making it "more attractive" to potential financial and...

Imfinzi's success in small-cell lung cancer pits it against Roche's Tecentriq, as both are now ahead of Merck's Keytruda.

The results are a boost for Lilly's drug, tirzepatide, which is being prepared for regulatory submissions later this year. But long-term heart data...

The studies offer perhaps the most concrete rebuttal yet to an idea that GLP-1 drugs, which have profound benefits on weight loss and heart health, might also...

The company declined to comment on Gottlieb’s appointment, which comes as it works to improve its relationship with federal regulators.

Sarepta, though, may try to seek accelerated approval using Phase 2 data that's due imminently, along with results from another, smaller trial.

Merck's surprise buyout of ArQule will heat up competition in a class of cancer drugs that includes AbbVie and J&J's Imbruvica and...

Outside experts debated the shot's safety profile and its efficacy versus the omicron variant but ultimately supported the vaccine, which is made...

The main patent for Ohtuvayre, the COPD drug at the heart of Verona’s $10 billion sale, expired in 2020. For Merck to make good on the deal, other secondary...

An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean...

The pharma has been criticized for not doing enough to make its COVID-19 vaccine and pill available globally. The new initiative commits Pfizer to supplying...

The deal hands Blackstone a piece of the potential future sales of an antibody-drug conjugate that could soon challenge marketed medicines from AstraZeneca and...

The COVID-19 vaccine maker is paying $200 million to secure rights to an experimental CTLA-4 inhibitor that privately held OncoC4 designed to have fewer side...

Walmsley, who helped push GSK to focus more exclusively on specialty medicines and oncology, will be succeeded by commercial head Luke Miels on Jan. 1.

Pharma would respond to Pelosi's proposal by raising list prices, keeping some drugs off foreign markets, and cutting R&D spending, according...

The drugmaker, which on Oct. 29 won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug...

After a private equity takeover unraveled this summer, the women’s health company is selling its drug portfolio to Mayne Pharma in a $153 million deal.

Aimmune's next challenge will be securing insurance coverage as people allergic to peanuts still have to avoid exposure to the food.

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.

The experimental vaccine is the most advanced candidate for the tick-borne disease and, if successful, would be the first to reach the market since withdrawal...

The Series A round was led by healthcare investor The Column Group, which made the 17-year-old biotechnology company private earlier this year.

Novartis has made a large investment in targeted radiotherapies, sparking competition from fellow pharma companies and young biotechs.

Safety worries led to a near-unanimous vote against roxadustat in kidney disease patients, dimming the approval chances of what would be the first pill to...

Approval of Merck's shot sets the stage for the two large pharmas to compete for market share with new pneumococcal vaccines that are meant to improve...

Indication-based pricing may be possible for less severe patients, who would receive a smaller dose. Lower manufacturing costs would lessen the blow to...

The new FDA approval expands Calquence's use into a more common blood cancer, although doctors have already been prescribing it for that disease.

As Novartis' gene therapy Zolgensma remains under scrutiny, the Swiss rival's risdiplam delivered positive results in older, less severely...

While Trump’s manufacturing and pricing deals with pharma shape the industry’s future, COVID’s impact still ripples throughout the health landscape.

Technology inspired by work at Yale researcher Craig Crews’ labs will be used to target prostate and breast cancer in early clinical trials.

Following years of development, the biotech’s heart failure drug now faces another hurdle in its regulatory path forward, after a group of FDA advisers took...

The new vaccine, which Merck will sell as Capvaxive, will compete with Pfizer’s blockbuster Prevnar franchise.

The regulator’s challenge will test a more expansive view of how pharmaceutical mergers could harm consumers. Amgen remains confident it can complete the...

When added to chemo, Merck's immunotherapy kept a difficult-to-treat form of breast cancer from progressing, provided patients had an important...

Known as Enflonsia, the drug will compete for market share with Sanofi and AstraZeneca’s in-demand Beyfortus, which quickly became a blockbuster medicine...

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change that could accelerate cell...

Data presented at AACR suggest a personalized shot made with messenger RNA may amplify the effects of a widely prescribed cancer immunotherapy.

2023 was a breakout year for GLP-1 drugs, which have shown dramatic weight loss benefits. Study results in August proved Novo’s Wegovy could protect the...

The Merck drug leads competitors Opdivo and Imfinzi into a new immunotherapy setting, which aims to improve outcomes following the surgical removal of tumors.

Venture investors are adopting a more aggressive mindset heading into 2026, while Merck, Moderna and Summit are all approaching crucial trial readouts.

Third Rock-founded Decibel, which has shed much of its value since a 2021 IPO, expected to run out of money within a year.

The planned $2.3 billion investment follows an earlier $6 billion commitment to expand manufacturing for drugs like its in-demand medicine Wegovy.

At an analyst day event, Moderna said it wants to invest revenue from a hopefully expanded seasonal vaccine franchise into oncology and rare disease programs,...

The agency's decision was based on U.S. government travel restrictions, but it said "alternative tools and methods" will help it...

An Alzheimer’s drug from Eli Lilly, BioMarin’s hemophilia gene therapy and a new type of breast cancer treatment are among the top decisions on the...

The purchase would give Abbott access to cancer screening tests including Cologuard and blood tests for multi-cancer early detection.

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

Fresh data from multiple studies suggest the drug, which Sanofi has billed as a future blockbuster, could be cleared in the U.S. but has murky sales prospects.

Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of...

Rival companies have set a standard in lymphoma and leukemia. Now the Swiss drugmaker wants to be a pioneer in cell treatments for solid tumors.

The deal, one of two multibillion-dollar buyouts from Merck this year, centers around a drug that could become an alternative to vaccines for flu prevention.