FDA walks back plan to alter generic names of already approved biologics

Introduction of biosimilars in the U.S. has forced the FDA to evaluate how best to distinguish biologic products, a regulatory process with broader implications than it might seem.

By Ned Pagliarulo • March 7, 2019

How Scott Gottlieb changed the FDA

The agency head, who will leave after two years on the job, departs with a legacy as an outspoken leader who pushed the agency forward on several fronts.

By Andrew Dunn • March 6, 2019

5 takeaways from Scott Gottlieb's surprising FDA departure

The FDA chief's exit spurs a number of questions for the pharmaceutical industry, including who will replace him and why he's leaving.

By Jacob Bell • March 6, 2019

FDA Commissioner Scott Gottlieb resigning, to leave in one month

Gottlieb led the agency for nearly two years, winning plaudits as an effective commissioner. His resignation surprised many in D.C. and in industry.

By Ned Pagliarulo , Andrew Dunn • March 5, 2019

Aimmune has its answer on peanut drug's status, but how FDA proceeds still unclear

The biotech says it will know in one month whether the FDA has accepted its drug application, which was derailed by the 35-day government shutdown.

By Ned Pagliarulo • March 1, 2019

Akorn's Amityville plant draws critiques from FDA

Inspectors from the agency flagged maintenance, testing and record-keeping issues at the New York plant, adding to the company's recent woes.

By Kristin Jensen • Feb. 28, 2019

Gottlieb pledges device, drug reviews will be on time post shutdown

The FDA chief's testimony follows introduction of a bill to allow the agency to accept new device applications and fees during a government shutdown.

By David Lim • Feb. 28, 2019

Hurdles of antibiotic R&D on display in Achaogen's divergent study outcomes

A NEJM editorial highlighted the challenges still facing companies in antibiotic development, particularly in serious resistant infections.

By Suzanne Elvidge • Feb. 27, 2019

Pharma's day in Congress: 'A hearing not a show'

Drugmaker executives avoided major missteps, but senators were successful in wringing acknowledgement that the current system isn't working.

By Ned Pagliarulo , Andrew Dunn • Feb. 26, 2019

In front of Congress, pharma execs blame 'broken' system

Top officials from the industry's largest drugmakers are testifying on drug pricing today in a Senate hearing billed as a showdown on the contentious issue.

By Ned Pagliarulo • Feb. 26, 2019

How lawmakers could pressure top pharma execs in Senate hearing

Here's a guide to the political pressure points for each of the seven drug companies in front of the Senate Finance Committee today.

By Ned Pagliarulo • Feb. 25, 2019

Insulin drugmakers again come under Senate scrutiny

Eli Lilly, Novo Nordisk and Sanofi now face pressure on their pricing practices from several key Congressional committees, including Senate Finance.

By Ned Pagliarulo • Feb. 22, 2019

In unusual step, FDA pushes back against reports on questionable generic drug quality

A statement from agency chief Scott Gottlieb and CDER head Janet Woodcock defended their oversight of generic drugs imported from abroad.

By Ned Pagliarulo • Feb. 22, 2019

FDA to accept drug plant inspections by Poland, Slovenia

So far, the regulator has recognized health authorities in 22 EU countries, trusting information those agencies gather through GMP inspections.

By Ned Pagliarulo • Feb. 21, 2019

After accelerated approval, Merck's Keytruda fails in liver cancer study

The negative results raise questions about Keytruda's earlier OK, which was based on findings from a smaller Phase 2 trial.

By Andrew Dunn • Feb. 20, 2019

Roche gains quick review for two cancer drugs

Priority review from the FDA could mean entrectinb and polatuzumab vedotin join the ranks of Roche's oncology medicines later this year.

By Suzanne Elvidge • Feb. 19, 2019

FDA clarifies pathway for devices used in regenerative medicine

The final guidance document covers instruments, machines and implants used in conjunction with cell-based and gene therapies.

By Susan Kelly • Feb. 19, 2019

CMS unveils CAR-T proposal, with emphasis on patient outcomes

High price tags and a potential one-time administration have challenged CMS to figure out reimbursement for CAR-T cell therapies.

By Jacob Bell • Feb. 15, 2019

Novartis secures regulatory 'fast pass' in US OK for tropical disease drug

With the FDA's nod, Egaten is now the first approved therapy in the U.S. for an infectious disease caused by parasites found in contaminated food and water.

By Kristin Jensen • Feb. 14, 2019

J&J's esketamine wins backing of key advisory panel

Committee experts recommended the FDA approve the depression drug, giving cover for the agency to take a more flexible approach in its review.

By Ned Pagliarulo • Feb. 12, 2019

Immunomedics, still searching for first approval, discloses forthcoming FDA re-inspection

The agency will re-inspect a New Jersey manufacturing facility as part of a regulatory resubmission for the company's lead drug candidate.

By Andrew Dunn • Feb. 8, 2019

Approving J&J's new depression drug would be an unusual move for the FDA

Esketamine's clinical track record could raise questions about its efficacy, which will be a key topic during a joint advisory committee meeting next week.

By Jacob Bell • Feb. 8, 2019

FDA draft lays out submission paths for combo products

Commissioner Scott Gottlieb said the agency will develop additional guidances outlining specific premarket considerations for combo products.

By David Lim • Feb. 6, 2019

Key Senate committee pressures 7 big pharmas to testify

Pfizer, J&J and AbbVie are among the major drugmakers invited by Senate Finance to discuss drug pricing at a hearing set for Feb. 26.

By Suzanne Elvidge • Updated Feb. 5, 2019

Alkermes' depression drug turned back by FDA

A Complete Response Letter was expected, after an advisory panel last year recommended against approving the biotech's experimental antidepressant.

By Suzanne Elvidge • Feb. 4, 2019