BioSpace

All the Ways Moderna’s Flu Vaccine Rejection Letter Shocked Us

The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
Lancaster Eagle-Gazette on MSN

Fairfield County sends Homestead exemption letters to participants

Fairfield County homeowners in the Homestead program are advised to check their exemption status as annual letters arrive.

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forward mRNA-1010 has been ...

Gov. Gianforte solicits applications, nominations for Sixth Judicial District judgeship

Gov. Greg Gianforte is accepting applications and nominations to fill a district court vacancies in the Sixth Judicial ...

How to apply for ANCHOR, Senior Freeze, Stay NJ using one application

New Jersey residents can now apply for property tax relief programs using the PAS-1 form, which combines Senior Freeze, ...

EdgeMode Advances Form 211 Review Process Under SEC Rule 15c2-11

EdgeMode (OTC: EDGM), a global Energy and AI data center infrastructure company, today announced continued progress in the review of its Form 211 submission made by its sponsoring market maker to ...
PharmExec

FDA Sends Refusal-to-File Letter to Moderna for Seasonal Influenza Vaccine, Enters Long-Term Agreement with Government of Mexico

A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing ...
LiveLaw

Appointment Letter For Police Recruitment Can't Be Rescinded Over Non-Disclosure Of FIR Cancelled Before Application: P&H High Court

The Punjab and Haryana High Court has set aside the cancellation of appointment of a Haryana Police constable whose candidature was terminated for allegedly not disclosing an FIR that had ...
Times News Online

Letter to the editor: Adopting a kitten

My husband and I miss our beloved cat, who because of illness had to be put to sleep, so much we decided to adopt a kitten. With two dogs in our home we felt that an older cat might attack the dogs.
The Dominion Post

NextEra MARL application before PSC available for public review

Six binders totaling more than 3,000 pages. That, in physical form, is the NextEra Energy Transmission MidAtlantic ...

Outlook Therapeutics Submits Type A Meeting Request to FDA Following Complete Response Letter

Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence ...

Moderna, Inc.: Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forwardmRNA-1010 has been ...