Trump imposes up to 100% tariff on some brand name pharmaceutical companies

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

On Jan. 9, Pierre Fabre Pharmaceuticals received a “complete response letter” from FDA: its application for the T-cell therapy tabelecleucel (Ebvallo) was getting a hard No.

FDA debuts precheck manufacturing program to boost domestic drug development

FDA has launched a venture in onshoring domestic drug development called the Precheck Pilot Program.

February 06, 2026

Vol.52 No.05

By Claire Marie Porter

Cancer Policy

House passes Mikaela Naylon Give Kids a Chance Act—next step, the Senate

The U.S. House of Representatives unanimously passed the Mikaela Naylon Give Kids A Chance Act, a bill to accelerate pediatric cancer treatments and expand access to life-saving therapies for children battling rare diseases.

December 12, 2025

Vol.51 No.45

By Claire Marie Porter

City of Hope’s leadership in lung cancer: Precision, innovation, and a vision for cure

As we mark Lung Cancer Awareness Month, it is a time to acknowledge that screening and prevention are vital, and equally crucial is ensuring that patients have access to state-of-the-art care and research. Herein, I spotlight some of the transformative work underway at City of Hope.

November 07, 2025

Vol.51 No.41

By Ravi Salgia

News Analysis Regulatory News

Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism
Experts call the move “extremely premature”

FDA has initiated the approval of leucovorin calcium tablets, rushing them to market as part of a push from the Trump administration to identify potential treatments for autism spectrum disorder.

September 26, 2025

Vol.51 No.35

By Claire Marie Porter and Paul Goldberg

Cancer Policy

FDA advances rare disease drug development with new evidence principles

FDA introduced the Rare Disease Evidence Principles to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.

September 12, 2025

Vol.51 No.33

By Jacquelyn Cobb

Trump imposes up to 100% tariff on some brand name pharmaceutical companies

YOU MAY BE INTERESTED IN

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

FDA debuts precheck manufacturing program to boost domestic drug development

House passes Mikaela Naylon Give Kids a Chance Act—next step, the Senate

City of Hope’s leadership in lung cancer: Precision, innovation, and a vision for cure

Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism
Experts call the move “extremely premature”

FDA advances rare disease drug development with new evidence principles

Renew today!

Subscriber content

Never miss an issue!

Login

Trump imposes up to 100% tariff on some brand name pharmaceutical companies

YOU MAY BE INTERESTED IN

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncologyAtara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

FDA debuts precheck manufacturing program to boost domestic drug development

House passes Mikaela Naylon Give Kids a Chance Act—next step, the Senate

City of Hope’s leadership in lung cancer: Precision, innovation, and a vision for cure

Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autismExperts call the move “extremely premature”

FDA advances rare disease drug development with new evidence principles

Never miss an issue!

Login

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism
Experts call the move “extremely premature”