Food and Drug Administration (FDA)

The FDA approved Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. Also, Rozlytrek secured accelerated approval for the treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

Ultragenyx Pharmaceutical Inc. and GeneTx Biotherapeutics LLC announced a partnership to develop GeneTx’s GTX-102, an antisense oligonucleotide (ASO) for the treatment of Angelman syndrome, a serious, debilitating, rare neurogenetic disorder that affects approximately 1 in 15,000 people worldwide.

Akari Therapeutics, Plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for nomacopan for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy (HSCT-TMA) in pediatric patients.

The new designation granted to Calquence marks the 10th such designation the company has earned since 2014, AstraZeneca said.

The Democratic senators called it “unconscionable” that AveXis and its parent company Novartis would include manipulated data in order to rush a product to market.

Now that July has come and gone, the U.S. Food and Drug Administration is back to work approving drugs. This week marks three PDUFA target action dates, although one has already been rejected and another hit a snag that doesn’t appear to affect the decision date.

Before it finalizes the guidance, the FDA is seeking comment from drugmakers about the proposed plans.

Myriad Genetics, Inc. announced that the AstraZeneca/Merck Phase III PROfound studydemonstrated that men with metastatic castration-resistant prostate cancer who tested positive for germline and somatic mutations in homologous recombination repair genes benefitted from treatment with Lynparza®, a novel PARP inhibitor.

Former Touch Bionics CEO joins Adapttech as company secures FDA decision for medical device that improves prosthesis fit