The fast-tracked drug netted another indication today, this one for a form of leukemia. Lower dosage of the drug for that indication shrinks the price compared to lymphoma.
Two JAMA articles and an editorial give a rundown of what the FDA leaves unsaid in its approvals process and how general housekeeping items can get drugs rejected.
Reports are that the UK wants an expedited process that will mirror the FDA's.
The GlaxoSmithKline-Pfizer-Shionogi joint venture scored an FDA approval in August.
The FDA approved Orenitram (treprostinil), after rejecting it twice before.
The FDA's Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.
Janssen's hepatitis C drug Olysio (simeprevir) offers modest benefit over standard of care, but resistance in a subgroup of patients could hinder broader uptake.
The drugmaker's green light was paired with the EMA's decision that several thousand unreported AEs were no big deal.
Known as Breo Ellipta in the US, GlaxoSmithKline's Relvar Ellipta was approved by the EMA for asthma and COPD. The overall market is expected to continue to grow, but an NIH study indicates more patient conversations need to happen.
The company also has breakthrough therapy designations for CLL and Waldenstrom's macroglobulinemia.
A report says this year's approvals could be worth more than last year's, even though the number of approvals will be fewer.
The regulator approved the CLL medication Friday, giving the drugmaker time to create a marketing transition before Rituxan goes generic. The approval marks another milestone: the first drug approved with a Breakthrough Designation label, a tag that is now coming under scrutiny.
The FDA approved Novoeight, for hemophilia A patients.
Approvals and reviews continue—for now—despite government shutdown.
The FDA approved the drug maker's depression drug Brintellix, one day after the Danish company announced a reorg that includes shifting 180 to 200 jobs.
The second-line drug sped from Priority Review status for the first-line indication to approval in just over two months.
AbbVie and Galapagos go after cystic fibrosis; FDA's NME approval pace slows; government shutdown could slow ad-com votes; and a report shows privately insured patients had emptier pockets in 2012 than 2011
Biogen extend Isis relationship for six years and $100M; HHS readies healthcare reform TV push; Medivir ends hep. B clinical trial; FDA approves Celgene cancer drug; Baxter seeks Enbrel biosimilar
The FDA approved GlaxoSmithKline's second quadrivalent flu vaccine, but a CVS study indicates that consumers are big fans of the vaccination, as long as they aren't the ones rolling up their sleeves.
The GSK-Pfizer-Shionogi daily HIV medication gets the regulatory all-clear. The approval could put BMS/Gilead's best-selling daily med Atripla on the defensive.
GSK says change is afoot in China; Vivus fight reportedly results in a new CEO; Biogen Idec enters a collaboration in Edinburgh; Astellas wins and FDA approval; Myriad's patent fight continues
FDA's afatinib approval enables the drug maker set up shop in a new therapy space.
GSK's newest cancer approvals highlight a problem that stalks progress with personalized medicines.
The FDA approved the Breo/Ellipta combo, but analysts are wary about its potential to go beyond the COPD indication in the US.
Arena gets closer to the market place, Takeda scoops up privately held Inviragen, Plan B court decision is coming and Cubist antibotic lands breakthrough therapy status.
A new FDA site gives patients a one-stop shop for commenting on pending regulations, finding clinical trials and navigating treatment options.
FDA is accelerating review of Pfizer's experimental breast cancer drug palbociclib, which analysts say already has a fan base among KOLs.
The FDA has approved Janssen's Invokana (canagliflozin) for type 2 diabetes, giving J&J a first-to-market advantage in the SGLT-2 class.
Sobi and Savient Pharmaceuticals inked a co-promote agreement for RA drug Kineret in the US.
Johnson & Johnson is said to be shopping its women's division; Genzyme lands a rare disease drug approval; Roche says Avastin had a comeback in 2012; promotions at Ogilvy CommonHealth and McCann Complete Medical