Top Stories: Monday, Mar. 16

4 wks
FDA refuses to review Moderna mRNA flu vaccine application (15) hot
5 wks
FDA CRL halts AstraZeneca’s Saphnelo prefilled pen approval (5)
4 wks
CMS proposes sweeping changes to ACA marketplace plan rules (4)
4 wks
Tenet forecasts major ACA exchange enrollment drop and financial hit (6)
4 wks
City of Hope promotes Nisha Morris to senior marketing chief (4)


In Detail As of Mon, March 16, 2026, 19:03 pm, America/Chicago

FDA refuses to review Moderna flu vaccine / Beckers

Ella Jeffries / beckershospitalreview - Moderna has received a refusal-to-file letter from the FDA’s Center for Biologics Evaluation and Research for its biologics license application for mRNA-1010, its investigational seasonal influenza vaccine. The letter, signed by Vinayak Prasad, MD, chief …

#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #drugdevelopment #fda

Moderna's flu shot dilemma muddies 2028 break-even guidance

4 wks / endpoints / Max Bayer

The Old System Failed Patients. Change Must Go Further and Faster – Garo Armen

4 wks / oncodaily

PTC Therapeutics withdraws US filing for troubled Duchenne treatment Translarna

4 wks / endpoints / Ayisha Sharma

FDA rejects Moderna's mRNA flu vaccine application, for reasons with no basis in the law

4 wks / medicalxpress

What the Health? From KFF Health News: New Flu Vax? FDA Says No Thanks

4 wks / kffhealthnews

Controversy around FDA’s Prasad rises again after Moderna rejection, behavior allegations

4 wks / endpoints / Zachary Brennan

Jeff Coller: The FDA Just Refused to Review Moderna’s mRNA Influenza Vaccine Application

4 wks / oncodaily

FDA may consider Moderna's flu vaccine in a narrower group

4 wks / endpoints / Max Bayer

U.S. Health Officials Defend Rejection of Moderna’s Flu Vaccine

4 wks / nytimes / Christina Jewett

Moderna Says FDA Refusal to Review mRNA Flu Vaccine Contradicts Federal Rules, Prior Guidance

4 wks / medcitynews / Frank Vinluan

Prasad overruled vaccine review team, office director on Moderna flu shot

4 wks / endpoints / Zachary Brennan

FDA refuses to review Moderna flu vaccine

4 wks / beckershospitalreview / Ella Jeffries

FDA refuses to review Moderna’s mRNA flu vaccine

4 wks / healthcaredive / Delilah Alvarado

F.D.A. Refuses to Review Moderna Flu Vaccine

4 wks / nytimes / Christina Jewett and Rebecca Robbins

Moderna accuses FDA of shifting standard as agency refuses flu shot review

4 wks / endpoints / Max Bayer

Wednesday, February 11, 2026, 10:25 am / permalink 19026 / 15 stories in 4 wks


AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo / Endpoints

Anna Brown / endpoints - The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval in Europe ...

#healthcare #pharmaceuticals #biotech #drugdevelopment #fda

Former AstraZeneca senior staff charged with illegal trade in China

4 wks / endpoints / Nicole DeFeudis

Moderna says FDA refuses its application for new mRNA flu vaccine

4 wks / medicalxpress

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

4 wks / oncodaily

FDA delays approval of AstraZeneca’s injectable lupus drug

5 wks / beckershospitalreview / Ella Jeffries

AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo

5 wks / endpoints / Anna Brown

Monday, February 9, 2026, 12:21 am / permalink 18917 / 5 stories in 5 wks


CMS proposes sweeping ACA exchange rule / Healthcare Dive

Emily Olsen / healthcaredive - The CMS said the regulation should remove barriers to more affordable health plans, like catastrophic coverage, as enrollment on the exchanges falls following the expiration of stronger financial assistance.

#healthcare #governmentpolicy

Clinics Sour on CMS After Agency Scraps 10-Year Primary Care Program Only Months In

4 wks / kffhealthnews / Andrew Jones

CMS proposes sweeping ACA exchange rule

4 wks / healthcaredive / Emily Olsen

CMS offers rules to lower healthcare costs

5 wks / beckershospitalreview / Madeline Ashley

CMS plans to roll back limits on non-standard ACA plan options

5 wks / fiercehealthcare

Thursday, February 12, 2026, 12:21 pm / permalink 19084 / 4 stories in 4 wks


Tenet expects 20% ACA enrollment drop / Beckers

Alan Condon / beckershospitalreview - Dallas-based Tenet Healthcare expects a 20% reduction in ACA exchange enrollment this year with the expiration of enhanced premium tax credits set to pressure hospital earnings and payer mix. The company is projecting adjusted EBITDA of up to $4.8 billion…

#healthcare #governmentpolicy

ACA Subsidies Expired. Open Enrollment Ended. But It Will Still Take Awhile To Register the Results.

4 wks / kffhealthnews / Julie Appleby, KFF Health News

Obamacare sign-ups drop, but the extent won't be clear for months

4 wks / medicalxpress

Tenet expects $250M hit from loss of ACA subsidies this year

4 wks / healthcaredive / Sydney Halleman

Tenet Health outperforms in Q4, projects solid 2026 despite ACA exchange headwinds

4 wks / fiercehealthcare

Tenet expects 20% ACA enrollment drop

4 wks / beckershospitalreview / Alan Condon

Tenet caps ‘strong’ year as revenue exceeds $21.3B — 8 things to know

4 wks / beckershospitalreview / Alan Condon

Thursday, February 12, 2026, 12:21 pm / permalink 19083 / 6 stories in 4 wks


Nisha Morris Joins Executive Leadership Team as Senior Vice President – City of Hope / OncoDaily

oncodaily - City of Hope shared a post on LinkedIn: “We are pleased to announce that Nisha Morris has been appointed Senior Vice President and Chief Marketing and Communications Officer at City […]

#healthcare

John Carpten Leading Science That Gives Patients a Fighting Chance – City of Hope

4 wks / oncodaily

Nisha Morris Joins Executive Leadership Team as Senior Vice President – City of Hope

4 wks / oncodaily

Study reveals molecular impact on oxygen-starved brain of newborns, offers hints to reduce long-term damage

4 wks / medicalxpress

City of Hope names new marketing chief

4 wks / beckershospitalreview / Naomi Diaz

Thursday, February 12, 2026, 1:23 pm / permalink 19092 / 4 stories in 4 wks


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