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Dimerix Reports FDA IND Approval for Phase 3 Study of DMX-200 in FSGS

FDA IND approved for ACTION3 Phase 3 clinical study, paves the way for patient recruitment in the United States reports Dimerix.

AlloVir Reports FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s Posoleucel for Prevention of Multiple Life-Threatening Infections from Six Viruses in Allogeneic...

AlloVir advises Posoleucel’s third RMAT designation marks an unprecedented regulatory distinction among cell and gene therapies.

BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress due to...

BioCardia notes the first part of the clinical trial will evaluate increasing doses of the NK1R+ MSCs and the optimal dose will be taken to Phase II in a randomized study in adult patients recovering from ARDS due to COVID-19.

BiOneCure Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for BIO-106, a Novel TROP2 ADC for the Treatment of Advanced Solid Tumors

BiOneCure Therapeutics emphasized that the clinical study cleared by the FDA, known as StarBridge-1, is a Phase I/II, multicenter, open-label study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of BIO-106 as monotherapy and in combination with pembrolizumab in patients with advanced cancers.

Corium Receives FDA Approval of ADLARITY® (donepezil transdermal system) for Treatment of Patients with Alzheimer’s Disease

Corium notes ADLARITY is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of adverse GI side effects associated with oral donepezil.

Kairos Pharma Receives FDA Approval of Investigational New Drug (IND) Application for Its Phase 1 Clinical Trial of KROS 201 for the Treatment of...

Kairos Pharma advises the Phase 1 clinical trial of KROS 201 to begin in 2022 at Cedars Sinai Medical Center.

Updates on OLUMIANT® (baricitinib) Phase 3 Lupus Program and FDA Review for Atopic Dermatitis

"On behalf of all of us at Lilly, we thank the participants, trial sites and clinical investigators for their essential contributions to the OLUMIANT atopic dermatitis and lupus programs. We are disappointed for the millions of people who suffer from these complex and hard-to-treat autoimmune diseases and are in need of more treatment options, and we remain committed to pursuing treatment advances in immunology that can make life better for people around the world," said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Lilly. Read more.

Jacobio Receives IND Approval for Aurora A Inhibitor JAB-2485 from FDA

Jacobio plans to initiate a Phase I/IIa clinical trial in patients with advanced solid tumors in the US.

FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products

Release of the white paper concludes the efforts of the IWGACP. The FDA will consider the scientific opinions presented in the white paper, including having it peer-reviewed, as part of its overall efforts to help ensure the safety of talc-containing cosmetic products.

Meridian Bioscience Receives FDA-Clearance for the Curian® Campy Assay

"Curian Campy follows last year's successful launch of our Curian HpSA assay and is the next step in expanding our Curian test menu for gastrointestinal infections," stated Wes Lindsey, Ph.D., Vice President Global Research and Development - Diagnostics.

Syncona Cornerstones CHF 110 M Series B Financing in Anaveon

Following the Series B financing, Syncona has revalued its existing investment which has resulted in an 88% uplift[4].