New Drug Approvals

JUNE 26, 2025

“Menthol derivative WS-12 selectively activates transient receptor potential melastatin-8 (TRPM8) ion channels” Pakistan Journal of Pharmaceutical Sciences. 2007 Mar;41(3):285-94. . ^ Ma S, Gisselmann G, Vogt-Eisele AK, Doerner JF, Hatt H (October 2008). 21 (4): 370–378. PMID 18930858. 284 (7): 4102–4111. 28 May 2025.

FDA 48

FDA Clinical Trials Small Molecule FDA Approval 48

Molecule Blog

AUGUST 13, 2021

Announcing the first biopharma IP-NFT Transaction Funding the first longevity research project by utilizing intellectual property NFTs in the pharmaceutical space Summary The vote has passed, the decision is made: The Scheibye-Knudsen Lab will be the first research organisation to fund their longevity research via an IPNFT.

FDA Approval 52

FDA Approval DNA Small Molecule FDA 52

Agency IQ

JUNE 7, 2024

These products are also required to comply with certain labeling expectations and manufacturers are expected to follow a specific set of current good manufacturing practices ( a final rule issued in 2007). Dietary supplement products do not need approval prior to being marketed – unless they contain a new dietary ingredient (NDI).

FDA 40

FDA Science Production Marketing 40

Drug & Device Law

DECEMBER 21, 2023

We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are. Takeda Pharmaceutical Co. , While we know that a late-breaking holiday horror, such as T.H.

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

Regulations 59

Regulations Production FDA FDA Approval 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , 2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. Luitpold Pharmaceuticals, Inc. , Atkinson pointed out that the main exception – fraud on the FDA − to this otherwise not easily rebutted presumption of warning adequacy is preempted. 2d 898, 909-10 (W.D. 2013); Massa v. 3d 441 (E.D.

Production 59

Production FDA Approval Vaccine FDA 59

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. 124 (2007), which would also be knocked out by Dobbs if it sticks.

FDA Approval 127

FDA Approval Pharmacy FDA Drugs 127

Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. von Eschenbach , 495 F.3d 3d 695 (D.C. von Eschenbach , 525 F. 2d 952 (S.D.

FDA Approval 52

FDA Approval Clinical Trials Trials Drugs 52

New Drug Approvals

APRIL 27, 2025

3] It was patented in 1966 and approved for medical use in 1974. [6] 6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. It became generic in the EU in 2009, and the first extended-release generic was approved in the US in 2012. billion in 2004. [23]

FDA Approval 57

FDA Approval FDA Pharmacokinetics Licensing 57

Codon

MAY 29, 2025

The way we typically prepare white beans completely deactivates the mild toxin that could otherwise cause food poisoning, the highly venomous cone snail that produced that shell was long gone by the time you picked it up, and Botox has been safe to inject by licensed healthcare professionals since FDA approval in 1991.

Drugs 106

Drugs DNA RNA Laboratories 106

Codon

FEBRUARY 23, 2025

In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. 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.

Clinical Trials 79

Clinical Trials Virus Vaccine DNA 79