2005, FDA Approval and Pharmaceuticals

2005

FDA Approval

Pharmaceuticals

Gepirone

New Drug Approvals

JUNE 11, 2025

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review.

FDA

FDA FDA Approval Treatment Clinical Trials

FDA set to announce stricter criteria for COVID-19 vaccines to receive Emergency Use Authorization

The Pharma Data

SEPTEMBER 23, 2020

It is also expected that they will require data for an emergency clearance which is nearly as extensive as the information needed for a general approval. . These new guidelines mean it will take extra time for pharmaceutical companies to prepare their applications and for the regulatory body to review the data. Conor Kavanagh.

Vaccine

Vaccine FDA FDA Approval Pharmaceutical Companies

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Trending Sources

Landiolol

New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 Landiolol was approved for medical use in Japan in 2002, [10] [11] in Canada in November 2023, [1] and in the United States in November 2024. [12] Food and Drug Administration (FDA).

FDA

FDA Clinical Trials Treatment Trials

Seladelpar

New Drug Approvals

SEPTEMBER 8, 2024

4] Seladelpar was approved for medical use in the United States in August 2024. [1] 2007.05.007 Drug Discovery, Johnson and Johnson Pharmaceutical Research and Development, LLC, 8 Clarke Drive, Cranbury, NJ 08512, USA Scheme 1. FDA” (Press release). Seladelpar cas 851528-79-5 C 21 H 23 F 3 O 5 S, 444.47 2007.05.007.

FDA

FDA Licensing Licensing FDA Approval

Roche’s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition

The Pharma Data

MARCH 5, 2021

Food and Drug Administration (FDA) approved Actemra ® /RoActemra ® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. 1-3 SSc affects about 2.5

FDA

FDA Disease FDA Approval Therapies

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science

Science FDA Production Packaging

Trospium chloride

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] billion in 2004. [23] billion in 2004. [23]

FDA Approval

FDA Approval FDA Pharmacokinetics Licensing

Why aren’t we better at weighing results and making sound conclusions?

SugarCone Biotech

MAY 28, 2019

A study, published in 2005, suggested that chloroquine could prevent SARS (the older virus) from infecting cells kept in culture. [2] The approval means the hypothesis will be tested in the public domain, without benefit of the clinical trial design that could tell us if its working, or not.

Vaccine

Vaccine Clinical Trials Virus Science

Pro Se Plaintiff Tries and Fails To Plead Claims For Failure To Withdraw And Failure To Warn

Drug & Device Law

MARCH 16, 2023

Indeed, she claimed FDA told the defendant to remove the drug from the market because of those risks in 2005, the year she was first prescribed it. But sue she did, so Beaver ends up as another case rejecting the silly stop selling theory of liability for an FDA-approved drug. 2023 WL 2386776, *3.

FDA Approval

FDA Approval FDA Testimonials Production

Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , Wyeth , 2005 WL 544222, at *6 (N.D. March 4, 2005), rev’d on other grounds , 462 F.3d 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. Genentech Inc.

Production

Production FDA Approval Vaccine FDA

Logical Contradiction Doctrine: Buckman for Textualists

Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. 440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. Albrecht , 139 S. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. 555 (2009), and rated only a “ cf.

FDA

FDA Regulations Production Government

For Preemption, “Newly Acquired” Does Not Mean “By Plaintiff”

Drug & Device Law

AUGUST 9, 2022

However, when it comes to federal preemption of a failure to warn claim involving a prescription pharmaceutical, the only new knowledge that counts is the FDA’s. Failure to warn is not preempted if the defendant could have changed the label without FDA approval via the Changes Being Effected (CBE) regulation.

FDA Approval

FDA Approval FDA Regulations Government

Drug Discovery Digest

Gepirone

FDA set to announce stricter criteria for COVID-19 vaccines to receive Emergency Use Authorization

Trending Sources

Landiolol

Seladelpar

Roche’s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Trospium chloride

Why aren’t we better at weighing results and making sound conclusions?

Pro Se Plaintiff Tries and Fails To Plead Claims For Failure To Withdraw And Failure To Warn

Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

Logical Contradiction Doctrine: Buckman for Textualists

For Preemption, “Newly Acquired” Does Not Mean “By Plaintiff”

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