New Drug Application Process

FDA approves a second generic abortion pill

F.D.A. Approves Generic Abortion Pill as Opponents Push Trump for New Restrictions

The Food and Drug Administration has approved a generic version of the abortion pill mifepristone, expanding its supply at a time when the Trump administration is under pressure from abortion opponen...

· 2h · on MSN

RFK Jr. said he had no choice but to approve abortion pill. Here’s what the law says

· 1d · on MSN

FDA approved new generic abortion pill before shutdown

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US regulator approves new generic abortion pill, conservatives outraged

US regulators have approved an additional generic version of the abortion pill mifepristone, a normally routine move that nevertheless angered anti-abortion activists.

Northwest Arkansas Democrat Gazette · 17h

FDA OKs generic abortion pill

MediaPost · 1d

FDA Approves Second Generic Abortion Pill

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FDA Approves Another Generic Abortion Pill, Prompting Outrage From Conservatives

Students for Life Action, which opposes abortion, in a statement Thursday called the approval “a stain on the Trump presidency and another sign that the deep state at the FDA must go.”

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Conservatives furious as FDA approves new generic abortion pill

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Trump FDA approves new generic abortion pill, angering conservatives

The Scientist

Understanding the Drug Development Process

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...

Cure Today

Ziftomenib Submits New Drug Application to FDA for R/R NPM1-Mutant AML

The FDA previously granted breakthrough therapy designation to ziftomenib for relapsed/refractory NPM1-mutant AML. A New Drug Application (NDA) has been submitted to the Food and Drug Administration for ziftomenib for the treatment of adult patients with ...

Disc Medicine Announces Submission of New Drug Application (NDA) to US FDA for Accelerated Approval of Bitopertin for Patients with Erythropoietic Protoporphyria (EPP)

Disc is seeking accelerated approval and priority review of its NDA submissionFDA decision to accept and file the NDA for review occurs within 60

Crain's Chicago Business

AbbVie files application for new drug combo to fight leukemia

AbbVie is seeking a new way to fight chronic lymphocytic leukemia, or CLL, by combining its oncology drug Venclexta with another cancer-fighting drug. The North Chicago-based drugmaker has filed a supplemental New Drug Application with the U.S. Food & Drug ...