Moderna, Takeda and Capricor on the verge of notching big drug approvals

Two of the companies are taking a second-go at FDA approval this summer, while another hopes to cement its leader-status in ...
Nasdaq

ADMA Biologics Receives FDA Approval for Innovative Yield Enhancement Process, Paving the Way for Increased Production Capacity and Revenue Growth

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA approval of ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
Fierce Pharma

Orca Bio makes a splash with FDA approval for cell therapy Tregzi. Could an IPO come next?

Orca Bio has jumped into the commercial market with FDA approval for Tregzi, a first-of-its-kind engineered cell therapy for blood cancer patients requiring transplants.    | Orca Bio has jumped into ...
RAPS

Tougher FDA Approval Process for Opioids Sought by Congress

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...
STAT

U.S. health officials inject new uncertainty into approval process for Covid boosters

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
JD Supra

New FDA Guidance Aims to Simplify the Biosimilar Approval Process

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...

The FDA keeps breaking its word to dying patients

For the past year, the Food and Drug Administration has done the exact opposite of what it promised. Leaders pledged to ...
Boston Herald

FDA proposes new system for approving customized drugs and therapies for rare diseases

WASHINGTON (AP) — Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions ...