The Latest Breaking News from FDA

Renalytix plc (NASDAQ:RNLX) has launched its new provider access portal, myIntelX, to provide nationwide online access for physicians to order KidneyIntelX bioprognostic testing. KidneyIntelX enables early-stage diabetic kidney disease (DKD) progression risk assessment by combining diverse data inputs, including blood-based biomarkers and personalized health data. It employs a proprietary algorithm to generate a…

Since the coronavirus pandemic began in early 2020, the FDA's plate has been full with reviews of COVID-19 vaccines and treatments. That has put the approval of many other drugs and therapies on the back burner.

The experience in Texas shows that workarounds pose daunting obstacles to such laws.

Michael Mullette, a former Moderna (NASDAQ:MNRA) vice president is taking a senior leadership position in the MAPS Public Benefit Corporation, a biotech company in the psychedelics sector. The MAPS PCB is a for-profit company wholly owned by the Multidisciplinary Association for Psychedelic Studies, a nonprofit founded in 1986 to advance patient…

UnitedHealthcare has added Kala Pharmaceuticals Inc's (NASDAQ:KALA) Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% as a covered brand on its commercial formularies effective March 2022.  Eysuvis now has coverage for approximately 118 million lives or 70% of all commercial lives. Kala also announced that Cigna Medicare had added Eysuvis as a preferred brand effective…

A spending bill provision would redefine "tobacco products" to include products that have nothing to do with tobacco.

Valneva SE (NASDAQ:VALN) completed the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. Valneva posted topline results from the phase 3 trial in August last year. The primary endpoint result is mainly unchanged from that data drop.  The removal of two subjects from the analysis increased the proportion of participants with protective…

Owlet Inc (NYSE:OWLT) reported FY21 sales of 75.8 million, just 0.6% higher than the $75.4 million reported a year ago.  The Company noted that through the first three quarters of 2021, revenues were $78.4 million, up 44% Y/Y, but early in Q4 FY21, Owlet received an FDA Warning Letter, resulting in halting sales…

Here's a roundup of top developments in the biotech space over the last 24 hours:

Robert Califf must demand transparency and accountability from the bureaucrats.

The FDA has completed a safety review of Inventiva SA's (NASDAQ: IVA) IND application and