USFDA

Join WhatsApp Channel

- Read more about AstraZeneca’s & Lilly’s AZD3293 receive FDA Fast Track designation
AstraZeneca and Eli Lilly and Company (Lilly) today announced they have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial.
- Read more about U.S. FDA approved Expanded Indication on Edwards SAPIEN 3 Transcatheter Heart Valve
Edwards Lifesciences Corporation announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis who have been determined by a Heart Team to be at intermediate risk for open-heart surgery. The SAPIEN 3 valve is the first transcatheter aortic valve replacement (TAVR) therapy to obtain this indication in the United States.
- Read more about US FDA grants orphan drug status to Pulmatrix's inhaled drug
The US Food & Drug Administration (FDA) has granted orphan drug status for Pulmatrix Inc's inhaled drug for treating pulmonary fungal infections in cystic fibrosis (CF) patients, named PUR1900.
- Read more about AMERIGEN generic version of Temodar approved by FDA
Amerigen Pharmaceuticals Limited announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg).
- Read more about Zymeworks’ ZW25 and ZW33 Granted Orphan Drug Designation by U.S. FDA
Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zymeworks’ lead investigational products ZW25 and ZW33 for the treatment of ovarian cancer. Orphan drug designation qualifies Zymeworks for a number of development incentives including tax credits for clinical testing and marketing exclusivity for a period of seven years if ZW25 or ZW33 is approved for this indication.

[adsense:336x280:8701650588]
- Read more about Novogen Submits IND Application To The USFDA for Contrail In Ovarian Cancer
Australian oncology-focused biotechnology company Novogen Ltd announced that it has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for Cantrixil (TRX-E-002-1) in ovarian cancer.
- Read more about Neurotrope Submits an Amended Protocol for its Phase 2b Clinical Trial of bryostatin-1 to the U.S. FDA
Neurotrope, Inc. announced that its wholly owned subsidiary, Neurotrope BioScience, Inc., has submitted to the Food and Drug Administration (FDA) an amended protocol for its Phase 2 clinical trial of lead candidate bryostatin-1 for the treatment of advanced Alzheimer’s disease. As planned in the original protocol, the primary efficacy outcome will occur at Week 13, and does not change with this amendment.
- Read more about US FDA issues updated recommendations on submitting new 510(k) for medical device modifications
The US Food and Drug Administration (FDA) issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
- Read more about Coherus Biosciences Submits 351(K) BLA To U.S.FDA For CHS-1701
Coherus BioSciences, Inc. announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to U.S. FDA under the 351(k) pathway.

[adsense:336x280:8701650588]
- Read more about Alkermes Submits sNDA to FDA for Two-Month Dosing Option of ARISTADA
Alkermes plc announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a two-month dosing interval of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.