The Latest Breaking News from FDA

FDA Recommends At Least 15 years Of Follow-Up For Genome Editing Product Trials

The FDA has outlined new draft guidance on what should be submitted in a clinical trial application and potentially concerning safety issues to track the genome editing products.

Benzinga · Mar 15, 2022

Smart For Life Agrees To Acquire Vitamin & Supplement Company Ceautamed For Undisclosed Sum

Smart For Life Inc (NASDAQ:SMFL) has agreed to acquire the vitamin and supplement company Ceautamed Worldwide LLC and its affiliates, Wellness Watchers Global LLC and Greens First Female LLC. The financial terms of the transaction were not disclosed. Ceautamed, based in Florida, is principally engaged in the development and distribution of nutritional products, including antioxidant…

Benzinga · Mar 15, 2022

Psyched: Albert Labs Goes Public, Ex-Moderna Executive Joins MAPS, Novamind and Usona Join For Phase 2 Psilocybin Trial

A new company has entered the public psychedelic markets, with an alternative drug-to-market approach. Using Real World Evidence trials, Albert Labs is expecting to legally provide psilocybin to patients in the UK much earlier than companies working with to get FDA approval.

Benzinga · Mar 15, 2022

Wesana Health One Step Closer To Clinical Trials Of Psilocybin And CBD Based Treatment Of Brain Injury Related MDD

Wesana Health Holdings Inc. (OTCQB:WSNAF) (CSE:WESA) have received a full written response from the Food and Drug Administration regarding their pre-investigational new drug meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of traumatic brain injury related major depressive disorder.

Benzinga · Mar 14, 2022

FDA Declines To Approve AstraZeneca's Asthma Treatment For Chronic Nasal Condition

The FDA has declined to approve AstraZeneca Plc's (NASDAQ:AZN) asthma medicine, Fasenra (benralizumab), to treat chronic rhinosinusitis with nasal polyps, a condition characterized by benign growths that cause pain and stuffiness. The FDA has issued a complete response letter following AstraZeneca's application to extend the use of Fasenra and requested additional clinical data…

Benzinga · Mar 14, 2022

Test to Treat: pharmacists say Biden’s major new Covid initiative won’t work

Program to facilitate access to antivirals will have a limited impact because pharmacists are restricted from prescribing the pills

The Guardian - US · Mar 14, 2022

Alzheimer’s patients divided on costly new drug: a ‘magic pill’ or ‘risk I’m willing to take’

Medicare has proposed limiting coverage of Aduhelm. Key groups representing patients and families are pressing to make it more widely available. Among people facing the disease, the outlook is more nuanced.

Chicago Sun-Times · Mar 11, 2022

U.S. Senate Appropriations Committee Directs FDA To Regulate CBD And Study Products On The Market

Under Sec. 741 of Division A(p.120), the U.S. Senate Committee on Appropriations has requested for the U.S.

Benzinga · Mar 11, 2022

4 High-Yield Tobacco Stocks to Add to Your Dividend Portfolio

Stringent FDA regulations imposed on nicotine consumption have hindered the tobacco industry’s growth over the past few years. However, manufacturers have produced various alternatives, like e-cigarettes, vapes, and similar smoking substitutes, which could help the industry grow. So, we think high dividend-yielding tobacco stocks Philip Morris (PM), British American (BTI),…

StockNews.com · Mar 11, 2022

ACHV: 2021 Results: ORCA-3 Underway, ORCA-V1 Soon to Start

By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT

Benzinga · Mar 11, 2022