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FDA, Pfizer and Moderna

FDA Asks Pfizer/BioNTech, Moderna To Add Myocarditis Risk to COVID-19 Vaccines

The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge the agency’s directive. The products' labels already include myocarditis warnings,

BioSpace · 1d

Healio · 6h

FDA committee recommends formula for fall COVID-19 vaccines

· 1d

FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

The FDA plans to limit access to covid vaccines. Here’s why that’s not all bad.

Covid vaccines will soon be required to go through more rigorous trials to ensure that they really are beneficial for people who aren’t at high risk.

MIT Technology Review · 17h

· 2d

FDA limits access to COVID-19 vaccine to older adults and other high-risk groups – a public health expert explains the new rules

STAT · 10h

FDA gives Covid vaccine manufacturers instructions for next fall’s shot

US FDA Advisers to Weigh Composition of COVID Vaccines for 2025-2026

Public health experts say that there is no certainty on which strains are going to be dominant.

· 1d

With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations

· 1d

FDA panel debates COVID vaccine recipe as questions swirl about fall shots

Fierce Biotech3d

Pfizer pays 3SBio $1.25B for PD-1xVEGF bispecific, joining red-hot race with BioNTech, Merck

Pfizer has joined the PD-1xVEGF bispecific gold rush. The Big Pharma is paying 3SBio $1.25 billion upfront for ex-China rights to a clinical candidate, establishing itself as a challenger to BioNTech,

10hon MSN

What we know about the safety, efficacy of mRNA vaccines amid recent scrutiny

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.

1don MSN

Changes are happening around COVID-19 vaccines: Here's what to know

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.

BioSpace13h

FDA Vaccine Advisors Agree on COVID-19 Vaccine as New Framework Looms as ‘Elephant in the Room’

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

Fierce Pharma13h

Fierce Pharma Asia—Pfizer's PD-1xVEGF bet; An Alzheimer's blood test approval; Samsung's biosim spinoff

Pfizer is paying $1.25 billion to join the PD-(L1)xVEGF bispecific race. | Pfizer is paying $1.25 billion to join the PD-(L1)xVEGF bispecific race. The FDA has granted its first official approval to a blood-based Alzheimer's disease test in a potential boon to anti-amyloid drugs.

3don MSN

Pfizer makes a $6 billion run into a new cancer drug race, 6 months after rival

Pfizer jumps into cancer-treatment race with a $6 billion licensing deal with a China-based company, six months after Merck’s move for a lot less money.

Pharmaceutical Technology on MSN2d

BioNTech to invest up to $1.34bn in UK R&D

"BioNTech to invest up to $1.34bn in UK R&D" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been inc

BioPharma Dive1d

FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K. regulators cleared Sarepta to restart an Elevidys study and Altos Labs bought a startup.

Cancer vaccines could make Britain science 'superpower' with £1bn BioNTech deal

Government signs deal to see huge investment in mRNA vaccine manufacturing which could help tackle the next pandemic and prevent cancers before they develop