New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. and > 300 mg/mL at lower pH pKa 4.8 2021 Jan 1;31:127624.

Clinical Trials

Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

FDA

The Pharma Data

NOVEMBER 4, 2020

In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 Licensing and royalty revenue. The increase was also driven by VASCEPA sales outside of the United States of approximately $0.5 million and $8.9 million and $5.7 million and $1.1

Production

Codon

JULY 14, 2024

Biotechnology Journal (2013). Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. A cost analysis to make one unit of red blood cells from stem cells. Data from Rousseau G.F. Each particle includes a lipid shell and a liquid core containing biomolecules.

Production

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. 13) McGee v.

Testimonials

Drug & Device Law

FEBRUARY 2, 2023

2013); Massa v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. Novartis Pharmaceuticals Corp. , 2d 898, 909-10 (W.D. Genentech Inc.

Production

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

FDA Approval

New Drug Approvals

APRIL 27, 2025

13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15] 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] November 2013). billion in 2004. [23]

FDA Approval

New Drug Approvals

APRIL 27, 2025

3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] Food and Drug Administration (FDA). Jump up to: a b c d e f g h i j k “FDA approves imaging drug for evaluation of myocardial ischemia” U.S. Food and Drug Administration (FDA). 2013 Jan 29;61(4):469-477.

FDA

New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 2013 Jun 11;110(24):9992-7. June 2013). Jump up to: a b c d e f g h i j k “FDA approves drug for heart disorder caused by transthyretin-mediated” U.S.

FDA Approval

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. This has happened before with other drugs.

Clinical Trials