The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

Labelling 40

Labelling FDA Vaccines Communication 40

pharmaphorum

AUGUST 27, 2020

Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder that could render current supplies unusable. Now, tragically, there is zero credibility for the upcoming @US_FDA review of #SARSCoV2 vaccines in the months ahead.

FDA 105

FDA Mayo Clinic Labelling Communication 105

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Immunization 78

Immunization Vaccines Communication Labelling 78

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

Vaccines 59

Vaccines Immunization Medical Schools FDA 59

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

Vaccines 53

Vaccines Immunization Medical Schools FDA 53

PharmaShots

APRIL 3, 2023

of the newly combined company The combined companies’ focus is to advance Elicio’s lymph node-targeting amphiphile technology to develop immunotherapies & also focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors is currently being evaluated in the P-I trial (AMPLIFY-201) for PDAC and CRC. ORR (41.8%

FDA 40

FDA Compounding Hospitals Vaccines 40

The Checkup by Singlecare

MARCH 28, 2024

Food and Drug Administration (FDA) to treat many bacterial infections. Amoxicillin is FDA-approved for treating nose, throat, ear, lung, skin, and urinary tract infections. It may also be prescribed off-label to treat other bacterial infections, including certain STDs. Amoxicillin is an antibiotic approved by the U.S.

Dosage 97

Dosage FDA Labelling Communication 97