Latest news with #FDAApproval
Wall Street Journal
3 days ago
- Business
- Wall Street Journal
How Moderna Went From Pandemic Hero to Vaccine Victim
Moderna MRNA 1.84%increase; green up pointing triangle was once a darling of the first Trump administration, which went to great lengths to help the company develop its Covid-19 vaccine that protected millions of people from the virus. Now the biotech is caught in the crossfire of Trump 2.0 as vaccine-making comes under fire. In the latest setback for Moderna MRNA 1.84%increase; green up pointing triangle, the Food and Drug Administration on Friday approved its next-generation Covid shot for a narrower population of patients than the company intended. The approval grants use of the vaccine only in older adults and people aged 12 to 64 with health risks.
Globe and Mail
21-05-2025
- Business
- Globe and Mail
NRx Pharmaceuticals (NASDAQ: NRXP) to Present at Wall Street Conference on May 21
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that Founder and CEO Dr. Jonathan Javitt will deliver a company update at the Wall Street Conference on May 21, 2025, in Palm Beach, Florida. NRx is one of six companies invited to present at the high-profile event, which is expected to draw more than 1,000 attendees representing over $1 trillion in investment capital. The presentation will highlight the company's progress toward FDA approval of NRX-100, a preservative-free intravenous ketamine formulation, as well as its strategic acquisition plans for HOPE clinics focused on treating suicidal depression, PTSD, and related conditions. To view the full press release, visit About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: Corporate Communications
Bloomberg
08-05-2025
- Health
- Bloomberg
RFK Jr. Takes Aim at Covid Shots for Kids, Worrying Vaccine Experts
Senior leaders at the US Food and Drug Administration began pushing Moderna Inc. and Pfizer Inc. to file for full, formal approval of their Covid vaccines for children last summer. The conversations gained urgency after President Donald Trump was reelected, and climbed higher when Robert F. Kennedy Jr., a vaccine critic, became the nation's top health official. It wasn't enough. By the time the applications were in hand at the agency, FDA employee departures had begun, slowing the work, according to a person familiar with the process who wasn't authorized to speak about it. They are still under review, as the number of political appointees who oppose the immunizations for children climbs.
