The Latest Breaking News from FDA

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.

In December 2021, Baxter International Inc (NYSE: BAX) issued an urgent safety communication about an issue with some of its Spectrum infusion pumps.

Solid Biosciences Inc (NASDAQ:SLDB) has reported two-year interim efficacy and safety data from the first three patients treated with SGT-001 in the high dose (2E14 vg/kg) cohort as part of IGNITE DMD.  Results suggest durable benefit 24-months post-administration of SGT-001 compared to natural history, consistent with results reported at the 12-month and 18-month…

Elektrofi and Immunoprecise Antibodies Ltd (NASDAQ:IPA) have collaborated to explore a high-concentration formulation of IPA's COVID-19 antibody cocktail, PolyTope TATX-03.  The collaboration aims to generate an IND-enabling data package for the FDA for an alternatively formulated version of TATX-03, named TATX-03E, that could be easily self-administered in a non-healthcare setting.  The parties anticipate formulating TATX-03E…

The FDA has extended the review period for Incyte Corporation's (NASDAQ:INCY) supplemental application for ruxolitinib cream (Opzelura) for vitiligo.  The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to July 18 from April 18. The FDA extended the PDUFA action date to review additional data from the ongoing Phase 3…

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.

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…

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

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.

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

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),…