The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. XmAb is a registered trademark of Xencor, Inc. Tax Petition.

Biosimilars 52

Biosimilars Production Treatment FDA 52

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

Engineering 87

Engineering Vaccine Production RNA 87

Agency IQ

JUNE 16, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. The rule, will also, if finalized, address communication with State boards of pharmacy.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

FDA 40

FDA Science Regulations Production 40

Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. Both propositions are well recognized, but Pfaff ties them together in one neat package.

FDA 59

FDA FDA Approval Regulations International 59

Drug & Device Law

JANUARY 4, 2024

2012), we hailed it as the best decision of 2012. The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. Hamilton , 372 S.W.3d

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59