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<![CDATA[How Recent FDA Actions Impact Sponsors]]>

<![CDATA[Your Questions Answered: Two FDA Approvals, Six Platform Deals, and a European Warning]]>

<![CDATA[What Moments in FDA’s Review Process Should Patients and Providers be Watching Closely?]]>

FDA starts review of Roche’s multiple sclerosis pill

The FDA previously hadn’t ever accepted an application of a drug like fenebrutinib in two major forms of MS. But safety questions still hang over Roche’s program.

Merck, Daiichi end plans to seek speedy approval of lung cancer ADC

The FDA indicated that the data generated so far wouldn’t support an accelerated clearance of “I-DXd,” a setback that erases an edge Merck and Daiichi had over multiple fast-moving...

FDA review docs spark Revolution sell-off; Zealand diabetes data underwhelm analysts

The new disclosure suggested Rasonque might not be as broadly effective as previously thought. Elsewhere, Ultragenyx got a much-needed cash infusion and TCGX started a China-focuse...

FDA Finalizes NDIN Identity and Safety Guidance

FDA warns three importers about missing foreign supplier documents

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...

FDA Releases 2025 CORE-EP Annual Report

Why FDA Clearance Alone Can’t Guarantee Medical Device Success

Why FDA Clearance Alone Can’t Guarantee Medical Device Success Anonymous (not verified) Thu, 10/15/2026 - 10:12 pharmagather item url Why FDA Clearance Alo...

The paperwork problem: How many FDA warning letters actually cite document failures

When people take a medication, they trust that it contains the right amount of active ingredient and is free of harmful contamination. Manufacturing and test records help verify th...

FDA OKs Lyrfigtu for previously treated bile duct cancer

The FDA approved lirafugratinib — a kinase inhibitor — for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma.The indication for lirafug...

FDA clears first generic radioligand drug; Sionna turns to layoffs

A Lutathera copycat has become the first “radioligand equivalent” cleared by regulators. Elsewhere, Novo dropped the “Nordisk” from its name and a novel RNAi drug showed early prom...

HLB resubmits FDA application for liver cancer treatment

Korean drugmaker HLB has resubmitted its application for U.S. approval of a combination therapy for advanced liver cancer, renewing its push to bring the target treatment to market...

Confirmatory Evidence for All? FDA’s Approval of Lytenava for Wet AMD Shows How Non-Rare Diseases Can Use Confirmatory E...

By Mark A. Tobolowsky & Frank J. Sasinowski —

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Fayuvi]]>

Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAI

By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

<![CDATA[Life Sciences Compliance: Diagnosis Incomplete]]>

FDA warns three Northeast food importers about missing supplier verification programs

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...

<![CDATA[FDA Approves Welireg Plus Lenvima for Previously Treated Adult Patients With ccRCC]]>

FDA cites juice processor for HACCP failures and lack of pathogen reduction

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...

U.S. FDA Leadership from Three Centers and OII Headline the Center Office Updates Session of the 2026 PDA/FDA Joint Regu...

PDA announced today that senior leaders from the FDA's centers for drugs, biologics and veterinary medicine as well as the Office of Inspections and Investigations will participate...

FDA Accepts Anaphylm Epinephrine Resubmission, Sets March 2027 Decision Date

The FDA accepts Anaphylm's resubmitted application, setting a March 2027 decision date for the needle-free epinephrine treatment. The post FDA Accepts Anaphylm Epinephrine Resubmis...

FDA places partial hold on Biohaven’s epilepsy drug

Announced mere weeks after Biohaven sold off rights to the therapy, opakalim, the halt affects a study some analysts believe is necessary to support a potential approval.