European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. MHRA announced that it will publish its guidance in 2024.

Medical 89

Medical Food and Drug Administration Manufacturing Safety 89

PM360

MARCH 22, 2024

Amor Vegas stated, “T cells have the ability to develop memory and persist in your body for really long periods, which is very different from a chemical drug. National Healthcare Benchmark Database. Car T cells can help slow down aging by attacking senescent cells that multiply with age but don’t die off. was approved by the U.S.

Food and Drug Administration 52

Food and Drug Administration FDA Healthcare Healthcare 52

Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This enhanced functionality will be made available commercially in 2024.

FDA 52

FDA Food and Drug Administration Recruitment Management 52

Pharmaceutical Technology

MAY 16, 2023

UniQure is selling a part of its royalty rights to the haemophilia B gene therapy Hemgenix (etranacogene dezaparvovec) to HealthCare Royalty and Sagard Healthcare for a gross purchase price of up to $400 million dollars. HealthCare Royalty is a royalty acquisition company. HealthCare Royalty is a royalty acquisition company.

Food and Drug Administration 52

Food and Drug Administration Healthcare Healthcare Sales 52

European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Medicine Pharma 97

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Australia’s Therapeutic Goods Administration (TGA) granted a provisional determination in April to Moderna’s Omicron jab, and in July to Pfizer’s Omicron jab.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Marketing 52

European Pharmaceutical Review

APRIL 30, 2024

In fact, we are working with the US Food and Drug Administration (FDA) and Massachusetts Institute of Technology (MIT) on a grant where the whole emphasis is on developing a continuous mRNA vaccine manufacturing platform. Sticking to the cell and gene therapy space, what’s your main prediction for 2024?

Manufacturing 77

Manufacturing Food and Drug Administration Biopharma Marketing 77

European Pharmaceutical Review

DECEMBER 18, 2023

At the beginning of this year, EPR reported on the potential blockbuster pharmaceutical drugs to watch in 2023. and subsequently enter into force in Denmark in July 2024. What will 2024 bring for the pharmaceutical industry? Since then, EPR has covered developments for several of the therapies highlighted in the report.

Manufacturing 95

Manufacturing Food and Drug Administration Medicine Pharmaceutical manufacturing 95

European Pharmaceutical Review

JANUARY 5, 2023

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants. MELODY clinical trials evaluating nirsevimab.

Food and Drug Administration 59

Food and Drug Administration FDA Safety Prescription 59

Legacy MEDSearch

SEPTEMBER 29, 2023

Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. Dr. Kasra Amirdelfan, Director of Clinical Research at Boomerang Healthcare, Inc. ReGelTec, Inc. announced that the U.S. Vapotherm (NYSE:VAPO), and National Sleep Technologies.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

World of DTC Marketing

MARCH 9, 2022

” Just before Trump assumed office, the outgoing Obama administration ran a tabletop exercise for the newcomers about dealing with a pandemic. His administration has undermined, suppressed, and censored government scientists working to study the virus and reduce its harm. In Texas, Greg Abbott has followed a similar playbook.

Food and Drug Administration 201

Food and Drug Administration Media Government Healthcare 201