The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. with Xolair since its initial approval in 2003. today announced that the U.S. indications. In the U.S., About Xolair.

FDA Approval 52

FDA Approval Clinical Development FDA Licensing 52

Drug Target Review

FEBRUARY 28, 2024

from 2003 to 2006, covering the biotechnology and life-science tools sectors. Normality sensing licenses local T cells for innate-like tissue surveillance. Regulation of cutaneous malignancy by gammadelta T cells. J Exp Med 198(5):747-755 (2003). Kabelitz D, Serrano R, Kouakanou L, et al. McKenzie D, Hart R, Bah N, et al.

Therapies 104

Therapies Engineering Molecular Biology Immune Response 104

Codon

FEBRUARY 27, 2024

It was March 2003, and an unfortunate 33-year-old, known only as patient YY, was suffering from intense diarrhea. A startup that makes such a spray has gained an EPA license to sell its product to customers in the consumer, commercial, and healthcare sectors. Read it on our website here. The man was in Hong Kong for kidney treatment.

Virus 75

Virus Hospitals Production Regulations 75

Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

FDA 40

FDA FDA Approval Regulations Production 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

FDA Law Blog: Biosimilars

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. This must be a U.S.-based

FDA Approval 59

FDA Approval FDA Drugs Compliance 59

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. A state-regulated cannabis industry better protects consumers than the illicit market or the unregulated intoxicating hemp-derived marketplace. January 29, 2024).

Regulations 59

Regulations Production FDA Approval Marketing 59