You are here: Industry Insights > FDA

News List

Novartis' Combination Therapy Tafinlar + Mekinist Granted FDA Priority Review for the Adjuvant Treat biospace
December 26, 2017
Novartis announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Supplemental New Drug Application (sNDA) application
FDA approves Ortho’s HIV diagnostic test biospectrumasia
December 25, 2017
The test is designed to identify HIV-1 and HIV-2 antibodies (Ab).
FDA Rejects Agile's Contraceptive Patch Twirla For a Second Time biospace
December 25, 2017
Shares of Agile Therapeutics plunged more than 62 percent in early trading after the company announced this morning the U.S. Food and Drug Administration rejected its low-dose hormonal contraceptive patch called Twirla.
La Jolla Pharmaceutical scores FDA approval for blood pressure treatment pharmafile
December 25, 2017
The U.S. Food and Drug Administration has announced that it has approved La Jolla's Giapreza (angiotensin II) injection for intravenous infusion
FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eli worldpharmanews
December 25, 2017
The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotonib) to include information for providers about how to discontinue the drug in certain patients.
FDA approves Spark Therapeutics’ Luxturna for retinal dystrophy pharmaceutical-technology
December 22, 2017
Spark Therapeutics has gained US Food and Drug Administration (FDA) approval for its one-time gene therapy product, Luxturna (voretigene neparvovec-rzyl), to treat children and adults with biallelic RPE65 mutation-associated retinal dystrophy.
Loxo Oncology Initiates Rolling Submission of NDA to FDA for Larotrectinib for the Treatment of TRK biospace
December 21, 2017
When considering options in the biotech sector, experts often look more into the major companies providing massive amounts of resources to new candidates.
3 Hottest Areas of Drug Development to Keep an Eye on in 2018 biospace
December 21, 2017
Arpita Dutt, writing for Zacks, predicts what the three hot areas for approvals are likely to be in 2018.
FDA pledges to crack down on homeopathy treatments pharmafile
December 20, 2017
Following in the steps of authorities in the European Union, Australia and the United Kingdom, the FDA has pledged to crack down on homeopathic treatments with a new “risk-based enforcement approach”, the US regulator has revealed in a draft guidance.
FDA publishes two draft guidances on developing targeted therapies pharmaceutical-technology
December 20, 2017
FDA has published two new draft guidance documents that will provide clarity to medical product developers on the agency’s recommendations for researching and developing the next generation of individualised therapies.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page