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Treatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.

Approval of Tivdak was based on promising results from a Phase III innovaTV 301 clinical trial, which demonstrated a 30% reduction in the risk of death in patients with recurrent or metastatic cervical cancer.

Approval of Libervant marks the first orally administered rescue medication for this age group to be cleared by the FDA for epilepsy.

Hercessi marks Accord BioPharma’s first biosimilar to be approved in the United States, with multiple indications for HER2-overexpressing breast and gastric cancers.

The lawsuit, filed the department of labor, alleges that Blue Cross improperly collected provider taxes from self-funded employer health plans.

In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a look at the organization's pipeline.

Approval update comes as a result of findings from Study 5310, which addressed Biktarvy’s pharmacokinetics, safety, and efficacy during pregnancy and postpartum periods in patients with HIV.

Beqvez, a one-time gene therapy, offers hope to patients with moderate to severe hemophilia B who use regular factor IX prophylaxis, suffer severe hemorrhages, or recurrent serious bleeding.

PanOmiQ is referred to as the fasted technology of its kind by the company.

The center will offer local residents with opportunities and training to enter the pharmacy work force.

Companies reported that the new formulation of Coartem met required pharmacokinetic profiles and displayed promising efficacy and safety treating malaria in infants.

Pivya has shown efficacy against bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics, provides a look into the potential of further indications for Coya 302 amid promising ALS study.

The latest news for pharma industry insiders.

In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a preview on what the nexts steps are after presenting positive data on Coya 302 for the treatment of ALS.

Company aims to provide affordable emergency treatment from overdoses of heroin, fentanyl, and prescription opioids.

Ojemda is the first systemic therapy approved by the FDA for the treatment of relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or a BRAF V600 mutation.

Lutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Approval comes amid positive results of a single-arm trial, showing a complete response rate of 77% in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.

Leaders in areas such as drug discovery, clinical development and market access will meet to discuss AI, failing life expectancy, and a new generation of talent.

LabConnect will utilize the consulting firm’s assets to improve its clinical trial services.

The new tests are reportedly more accurate at detecting early-stage pancreatic cancer.

In an interview with Pharm Exec Associate Editor Don Tracy, Alessandro Zannini, Global After-Sales Manager, Stevanato Group discusses the benefits of generative artificial intelligence.

Per the agreement, Cellares will integrate and automate some of Bristol Myers Squibb’s CAR T-cell therapies into its Cell Shuttle program.

The latest news for pharma industry insiders.

While human infections of the virus are rare, a strain recently appeared in dairy cows before infecting a human in Texas.

Acquisition includes rights to marketing in the European Economic Area, Thailand, South Korea, and other regions for oral treatment of mild to moderately severe dementia associated with Alzheimer disease.

Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio.

Data from the Phase III ALINA trial show that Alecensa reduced the risk of disease recurrence or death by 76% vs. platinum-based chemotherapy in patients with completely resected IB to IIIA ALK-positive non–small cell lung cancer.

Insight that can help smaller biotech companies prepare for commercialization in the world of big pharma.