The regulator noted in its early 2014 retrospective that it set a high mark for the number of approved rare disease drugs this year, and that insufficient information is the reason many breakthrough status requests get bounced.
Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.
The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).
Promacta was previously indicated for chronic immune thrombocytopenia.
Roche backs away from Chugai but embraces InterMune, Merck rumored on track to score first PD-1 approval, a new Ebola strain may have surfaced and JNJ scoops up experimental anti-TNF.
The FDA has approved Arnuity Ellipta for asthma.
Plegridy is the only pegylated beta-interferon drug approved for relapsing multiple sclerosis.
The FDA greenlighted the drug for three cancers.
The FDA approved the inhaled insulin last week.
Zontivity (vorapaxar) was approved for patients who have already suffered a heart attack or have arterial blockages in the legs.
The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.
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.
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