The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S.

FDA Approval 52

FDA Approval FDA Treatment Small Molecule 52

Drug Target Review

MAY 15, 2024

According to Patrick Malone, a principal at KdT Ventures in the US, clinical wins are rarities in biotech, where an estimated five or 10 percent of drugs that head into human testing actually get approved. After years of hype, the first AI-designed drugs fall short in the clinic. Drug Discovery & Development.

FDA Approval 59

FDA Approval FDA Science Marketing 59

Drug Discovery World

FEBRUARY 26, 2024

The US Food and Drug Administration (FDA) has approved monoclonal antibody Xolair (omalizumab) for immunoglobulin E-mediated food allergy in some adults and children one year or older for the reduction of allergic reactions (Type I).

FDA Approval 130

FDA Approval FDA Clinical Trials Trials 130

The Pharma Data

APRIL 14, 2021

Xolair for self-injection offers healthcare providers and appr opriate patients another administration option for more flexibility in managing their treatment. with Xolair since its initial approval in 2003. today announced that the U.S. indications. indications. Approximately 460,000 patients have been treated in the U.S.

FDA Approval 52

FDA Approval Clinical Development FDA Licensing 52

The Pharma Data

NOVEMBER 23, 2020

The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. months (Baas 2020), and this is expected to serve as a benchmark for further approvals. .”

FDA Approval 40

FDA Approval Trials Treatment Virus 40

Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

Science 40

Science FDA Clinical Trials Pharmacy 40

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm.

FDA Approval 59

FDA Approval FDA Production Therapies 59