News

The Well News on MSN2dOpinion

Released FDA Files Show Flawed Drug Approval Process

For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained ...
Medical Marketing & Media4h

FDA’s new national priority voucher program wants to speed up drug approvals while lowering drug costs

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

New medications coming soon: Here’s what’s been FDA approved in 2025 so far

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...
PharmTech9h

CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

FDA Greenlights Game-Changing UV Technology That Could Make Raw Milk Safer to Consume

In a groundbreaking move, the FDA has approved a new UV light-based process for sanitizing raw milk — one that preserves its ...
PharmExec7h

Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

FDA appoints biotech executive as top drug regulator under RFK Jr.

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...
Clinical Advisor1d

FDA Approves Prefilled Syringe Presentation for Shingles Vaccine

Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine process.

Houston-based Empower Pharmacy’s drugs raised red flags for FDA and other states, but not Texas

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

The FDA must be modernized for the era of personalized medicine

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...
Medscape7h

Can Medicare Afford the Perpetual Human?

As life-extending technologies and aging interventions proliferate, questions surround who will be granted access to a longer ...

Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...