The government agency released its latest guidance this week.
11 questions for the GW CEO on the watershed moment.
The approval answers one question but raises others.
Two FDA guidance documents aim to help pharma companies show the value of their drugs to payers beyond what's included in FDA labeling.
For one of President Trump's proposals for lowering the cost of drugs, the path to implementation could be long.
The Food and Drug Administration regulates more than a third of the U.S. economy. And its new commissioner, Scott Gottlieb, is trying to shake up how it does so.
The pace may even pick up again this year.
The research will also cover topics including disease awareness ads.
Gilead wins reversal of $2.5 billion payment order; Aimmune Therapeutics' peanut allergy therapy shows promise; AstraZeneca wins FDA approval on key cancer drug.
By allowing companies to claim a 50% tax credit for qualified clinical testing expenses, developing drugs for rare diseases became economically feasible for the first time.
Spark has priced its cure for a rare form of blindness at $425,000 per eye. But rather than the science or the cost, pharma is buzzing over the company's outcomes-based pricing model
FDA Commissioner Dr. Scott Gottlieb has been saying all the right things regarding digital health.
Biogen, UCB reportedly showing interest in Acorda acquisition; Kite Pharma and Pfizer to develop combo lymphoma therapy; hospitals to form generics nonprofit
Senate committee votes in favor of Azar as new HHS head; FDA and DoD launch breakthrough designation program; Walmart offers free opioid disposal solution
Celgene reportedly in talks to buy Juno; Novartis' Kymriah receives fast-track reviews in U.S. and Europe; BI's Gilotrif gets expanded approval in lung cancer
Although if approved, it's not likely to launch in the U.S. for quite some time.
Merck's Keytruda combo therapy succeeds in Phase-III lung cancer trial; FDA launches pilot to address trial transparency; Spark's Luxturna overpriced, ICER says
Pharma looks to Spark for pricing blueprint; Ipsen hires Amgen exec as CEO of North America; FDA could improve social-media approach, study finds
As we continue to debate the proper size and role of government in society, cast your eyes on recent polls by Gallup and Pew that found the majority of Americans felt their income tax was fair.
Allergan to cut 1,000 jobs; McKesson acquires RxCrossroads from CVS Health; Pfizer and Sangamo enter collaboration to develop ALS gene therapy
Utah Senator who backed Orphan Drug Act will not seek reelection; medicines more expensive in 2018; Spark's genetic therapy for rare blindness costs $850,000
Roche to buy Ignyta for $1.7 billion; FDA OKs Valeant eye drop for OTC sale; Kmart settles prescription drug fraud allegations
BI to pay $13.5 million for misleading marketing; ICER: CAR-T therapies more cost-effective than chemotherapy; FDA approves Roche's breast cancer combo therapy
Tax bill could lead pharma to move overseas; global pharma sales increased 45% in nine years; FDA OKs first gene therapy for rare retinal disease
The Every Try Counts campaign to change how smokers see their last attempt to quit.
Pharma industry spent $57 million on lobbying in 2016; Humana, private equity firms to buy Kindred for $4 billion; price of old glaucoma drug skyrockets
From gift bans to Google Assistant, POC to OPDP, MM&M staff members give their predictions on what to expect in healthcare marketing in 2018
CVS/Aetna deal will affect healthcare benefits; lawmakers pressure DEA to curb painkiller supply; Allergan and Richter's Vraylar sees positive results for bipolar depression
Pharma R&D return on investment falls to eight-year low; FDA approves Pfizer's biosimilar to J&J's Remicade; Novartis to downsize generics business
FDA approves first topical skin growth treatment; Teva to cut 14,000 jobs; Novartis Oncology CEO resigns