India will spend $79.6 million on strengthening its drug regulatory system after the WHO raised concerns about domestically produced cough syrups being linked children's deaths.

A blistering battle has broken out between the ALS Association and more than a dozen state and local chapters, which are resisting a move to dismantle their offices.

GSK CEO Emma Walmsley warned the U.K. is at a “tipping point” and risks falling short of government ambitions to become a life sciences superpower.

A Medicare official hinted the program might test a policy of paying less for drugs that receive accelerated approvals than for medicines granted traditional approvals.

Amgen's long-awaited pricing for its Humira biosimilar suggests the biggest winners may be health insurers and others in the supply chain, but not patients.

Pfizer was scolded by a U.K. pharmaceutical trade group after its CEO made misleading statements about the need to vaccinate young children against Covid-19.

CVS and Walmart are cutting pharmacy hours amid a pharmacist shortage that has plagued the nation’s biggest drugstore chains.

The pharmaceutical industry, the NAACP, a cancer center, and a nonpartisan think tank are all lobbying to expand Medicare coverage for obesity drugs.

Merck is discontinuing a trial of Keytruda in prostate cancer after interim data showed it was unlikely to meet the study's main goals.

Amazon is beefing up its Prime program for U.S. users with a new subscription that will allow members to get generic drugs for a total of $5 a month.

New American Academy of Pediatrics guidelines suggesting early and aggressive treatment to combat obesity are generating a backlash.

The FDA denied Eli Lilly accelerated approval for donanemab, a treatment for people with early-stage Alzheimer’s disease.

The European Medicines Agency has not identified any safety signals in the region related to the updated Covid-19 booster shot from Pfizer and BioNTech.

A large-scale study of a Johnson & Johnson HIV vaccine was stopped early because it was not effective.

Johnson & Johnson has vastly scaled back efforts to produce its Covid-19 vaccine as it faces slumping demand.

Drugmakers are prioritizing biologics over pills because under a new law, they have more time before becoming subject to Medicare price negotiations.

A physicians group is urging the FDA to hold an expert panel meeting to review the Leqembi Alzheimer’s drug before issuing a full-blown approval.

Pfizer 's CEO said the company is not in talks with China to license a generic version of its Covid-19 pill, Paxlovid, for use there.

“This regulatory loophole allows safety issues to propagate for years and years, placing patient safety at risk,” said Kushal Kadakia of Harvard.

The FDA is pressing pause on testing of experimental medicines more often, a side effect of the drug industry’s move into promising but less-proven technologies.

The American Academy of Pediatrics for the first time recommended physicians offer weight-loss drugs for children with obesity.

"We always thought that as there was more experience with mifepristone and misoprostol, that at some point, some of those distribution restrictions would be able to be lifted."

Pfizer told employees it plans to pull back on early-stage research into treatments for rare diseases, including viral-based gene therapies.

Investigators released a detailed case report about a patient who died after receiving lecanemab, providing a new glimpse into safety concerns with the Alzheimer's drug.

Retail pharmacies will be allowed to offer abortion pills in the U.S. under a regulatory change made by the FDA.

Good morning, everyone, and welcome to a new year. We hope the holiday respite was refreshing and inspiring, because that oh-so-familiar routine of online meetings, calls, and deadlines — otherwise known as work — has predictably returned. But what c

The Institute for Clinical and Economic Review cut its suggested price range for the Pfizer Covid-19 pill Paxlovid by more than 80%.

Provisions opposed by industry were dropped from a bill that makes it easier for the FDA to withdraw drugs approved under an accelerated timeline.

The FDA added Lilly's Mounjaro to its list of drugs facing shortages, highlighting the company's struggles to meet booming demand for the new diabetes injection.

AbbVie is leaving PhRMA and BIO, the two prominent pharmaceutical trade associations representing its interests in Washington.