Search results for Accelerated Approval

<![CDATA[ICER and Verdant Research Publish White Paper Examining FDA’s Accelerated Approval Pathway]]>

CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to expedite access to certain FDA-designated Class II and...

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices

Key Takeaways: Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) have announced the Regulatory Alig...

<![CDATA[FDA Extends Priority Review of Leqembi Iqlik Subcutaneous Injection ]]>

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

WEDNESDAY, April 29, 2026 — The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon...

CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices

On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the Regulatory Alignment for Predictable and Imme...

RAPID Response: CMS and FDA Team Up to Fast-Track Medicare Coverage for Breakthrough Devices

On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) jointly announced the Regulatory Alignment for Predictable...

<![CDATA[FDA Approves Foundayo Under National Priority Voucher Program]]>

New Plan Could Speed Medicare Coverage for Innovative Devices

FRIDAY, April 24, 2026 — A new proposal could make it easier for patients to access breakthrough medical devices through Medicare. On Thursday, federal regulators announced a plan...

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The Trump administration unveiled a new program to speed up Medicare coverage for breakthrough devices, touting that the new pathway cuts red tape for medical device companies to g...

<![CDATA[FDA Approves Datroway for Patients with Metastatic Triple-Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhi...

‘New era’: FDA grants expanded access to pancreatic cancer therapy

Suneel Kamath, MD, knows too well the sense of helplessness that comes with living through what he calls “the doughnut hole.”After compelling data from a late-stage trial are prese...

FDA Announces Real-Time Clinical Trial Pilot Program and Proof-of-Concept Studies with AstraZeneca and Amgen

What You Should Know The FDA has launched two proof-of-concept (PoC) real-time clinical trials (RTCT) that report endpoints and data signals to the agency as they occur. AstraZenec...

<![CDATA[FDA Expands Enhertu in Early HER2-Positive Breast Cancer]]>

<![CDATA[FDA’s Oncologic Drugs Advisory Committee Recognizes Favorable Risk Benefit for Truqap ]]>

F.D.A. Grants Early Access to Promising Drug for Pancreatic Cancer

Patients with one of the deadliest cancers have been pleading for an unapproved treatment that may prolong their lives.

Accelerating access, raising the bar: Key FDA developments over the past six months

Over the past six months, the US Food and Drug Administration (FDA) has pursued a dual regulatory agenda: expanding flexibility to accelerate development and access while sharpenin...

Real-time trials may ‘fundamentally transform’ research

An FDA initiative to implement real-world clinical trials could dramatically accelerate the pace at which new treatments become available to patients, according to physicians from...

FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug Daraxonrasib

May 01, 2026 -- Today, the U.S. Food and Drug Administration is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an ex...

BioCardia outlines Japan Shonin filing in ~7 months and targets ~19-month path to approval for CardiAMP

FDA Approvals in Oncology: January-March 2026

In the first quarter of 2026, the FDA issued nine approvals in oncology, including treatments for blood cancers, pancreatic cancer, and more. The post FDA Approvals in Oncology: Ja...

May 28 2026 - AbbVie snags FDA’s first ADC approval for ultra-rare blood cancer

May 28 2026 - AbbVie snags FDA’s first ADC approval for ultra-rare blood cancer admin Thu, 05/28/2026 - 11:51 Steady progress across the board today, with new appro...

<![CDATA[FDA Approves Bizengri for Adults with NRG1 Fusion-Positive Cholangiocarcinoma]]>

<![CDATA[FDA Approves Beqalzi for Relapsed or Refractory Mantle Cell Lymphoma, Inqovi in Combination with Venetoclax]...