The Latest Breaking News from FDA

Shares of Kaival Brands Innovations Group (KAVL) have gained more than 175% in price so far this year, driven primarily by the company’s success in winning a judicial stay of a marketing denial order issued by the U.S. Food and Drug Administration last year. However, considering the company’s lean profit…

HeartBeam Inc (NASDAQ:BEAT) has signed a professional services agreement with Triple Ring Technologies Inc to assist in the design and development of its Telehealth complete solution 3D vector Electrocardiogram (ECG) collection device for remote heart attack or myocardial infarction (MI) monitoring.  The joint partnership is a five-phase expedited device development project scheduled to be completed…

Intellia Therapeutics Inc's (NASDAQ: NTLA) CRISPR-powered T cell therapy has 

Truist has initiated coverage on Verastem Oncology Inc (NASDAQ:VSTM) with a Buy rating and $6.00 price target, equivalent to approximately 350% upside. Analyst Srikripa Devarakonda notes that trading at about 2-times cash, the stock is "undervalued" given its programs in two cancers. Devarakonda adds that the Verastem base case is supported by a…

Amryt Pharma Plc's (NASDAQ:AMYT) Q4 FY21 sales increased 29% Y/Y to $54.8 million, missing the consensus of $56.81 million. The growth was driven by metreleptin revenues that increased 44% to $31.9 million. Cash of $113 million at December 31, 2021 (2020: $118.8M) The Company reported a wider operating loss of $(50.5) million…

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…