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

Payers balk at HHS proposal to end federal PBM rebates

AHIP criticized the administration's plan as "well-intentioned but misguided." The payer lobby insisted rebate savings go directly to consumers, lowering premiums and cost-sharing.

By Shannon Muchmore • Feb. 1, 2019

Trump administration proposal takes aim at drug rebates

Billed by government officials as a sweeping reform, the plan aims to do away with price reductions paid by drugmakers to PBMs and insurers in Medicare.

By Ned Pagliarulo • Jan. 31, 2019

Mylan's Advair generic wins long sought-after FDA OK

Past rejections slowed Wixela Inhub's path to market, giving GSK ample time to prepare for the now-forthcoming competitive hit to its top respiratory drug. 

By Suzanne Elvidge • Updated Jan. 31, 2019

Gottlieb teases real-world data emphasis for FDA in 2019

The agency head highlighted four priorities this year that focus on using and implementing real-world evidence and data.

By Suzanne Elvidge • Jan. 29, 2019