Ad Header

PharmaLive

Slogan

The Pulse of the Pharmaceutical Industry

  • Filter By Category

  • Filter By Author

First Antibiotic With New Mechanism of Action Approved in Almost 20 Years

The U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.

Read More »

Bayer in frame to win first EU nod for high-precision cancer drug

The EMA recommended approving Vitrakvi to tackle tumors with a specific genetic mutation regardless of where the disease started.

Read More »

European panel clears GW Pharma cannabis drug

GW Pharmaceuticals’ marijuana-based treatment Epidyolex won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel for use as an additional treatment for two types of seizures.

Read More »

FDA Greenlights Soliris for Rare Autoimmune Disease

The U.S. FDA gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder in adults that express a specific biomarker.

Read More »

Pfizer’s Avastin biosimilar wins FDA approval

The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche Holding AG’s blockbuster cancer treatment Avastin.

Read More »

Vertex to file for U.S. approval of CF therapy in 2019

Vertex Pharmaceuticals Inc. will apply for regulatory approval during 2019 for the company’s triple combination of drugs to treat the life-shortening genetic condition cystic fibrosis.

Read More »

BioMarin’s Hemophilia A Gene Therapy Shows Promise in Clinical Trial

San Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.

Read More »

Novartis’ SMA Gene Therapy Treatment Approved by FDA, Priced at $2.125 Million

The U.S. Food and Drug Administration approved Zolgensma, a gene therapy that Novartis called a life-changing medicine, for children younger than 2 years of age who have been diagnosed with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 gene.

Read More »

Pfizer Acquires Rare-Drug Company Therachon for $810 Million

Pfizer announced plans to buy Therachon, a rare disease biotech company based in Basel, Switzerland.

Read More »

Sanofi wins U.S. approval to sell dengue vaccine but with major restrictions

The U.S. FDA gave Sanofi SA’s dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine can cause severe infections in some people.

Read More »

Ad Right Top

MedAdNews

Extensive pharmaceutical business and marketing intelligence. For back issues, please contact MDAD@kmpsgroup.com.

August 2019 Focus: AI, AR/VR, Top 200 Medicines, Lions Health Takeaways, and more!

Subscribe

Ad Right Bottom