Approval

Gilead's idelalisib hat trick

The FDA greenlighted the drug for three cancers.

MannKind's Afrezza approved

MannKind's Afrezza approved

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The FDA approved the inhaled insulin last week.

FDA OKs Merck clot drug

Zontivity (vorapaxar) was approved for patients who have already suffered a heart attack or have arterial blockages in the legs.

Latest Breakthrough nod goes to Novartis

The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.

J&J cancer med adds indication, lower dose

J&J cancer med adds indication, lower dose

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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.

JAMA studies look at FDA rejections and approvals

JAMA studies look at FDA rejections and approvals

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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.

UK seeks own Breakthrough Therapy program

Reports are that the UK wants an expedited process that will mirror the FDA's.

EMA approves ViiV's Tivicay

The GlaxoSmithKline-Pfizer-Shionogi joint venture scored an FDA approval in August.

Oral form of Remodulin approved

The FDA approved Orenitram (treprostinil), after rejecting it twice before.

FDA's 2013 so far: 26 approvals

FDA's 2013 so far: 26 approvals

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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.

J&J HCV drug OK'd; educational push planned

J&J HCV drug OK'd; educational push planned

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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.

Roche lands EU Kadcyla approval, ducks EMA criticism

The drugmaker's green light was paired with the EMA's decision that several thousand unreported AEs were no big deal.

GSK's Breo approved in Europe, COPD market may be underestimated

GSK's Breo approved in Europe, COPD market may be underestimated

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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.

FDA approves Imbruvica (ibrutinib) for MCL

FDA approves Imbruvica (ibrutinib) for MCL

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The company also has breakthrough therapy designations for CLL and Waldenstrom's macroglobulinemia.

Researchers say follow money, not FDA approvals

Researchers say follow money, not FDA approvals

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A report says this year's approvals could be worth more than last year's, even though the number of approvals will be fewer.

Gazyva's nod gives Roche a Rituxan successor

Gazyva's nod gives Roche a Rituxan successor

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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.

Novo hemophila drug approved

The FDA approved Novoeight, for hemophilia A patients.

FDA reviews continue for now

Approvals and reviews continue—for now—despite government shutdown.

Lundbeck scores FDA approval, reorganizes

Lundbeck scores FDA approval, reorganizes

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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.

FDA okays Perjeta for first-line breast cancer treatment

FDA okays Perjeta for first-line breast cancer treatment

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The second-line drug sped from Priority Review status for the first-line indication to approval in just over two months.

Business briefs: AbbVie, FDA, and health spending projections

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

Business briefs: Biogen, Celgene, J&J, plus Obamacare TV push

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

GSK clears another flu vaccine, but patients may not be buying

GSK clears another flu vaccine, but patients may not be buying

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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.

New daily HIV med could put Atripla on the defensive

New daily HIV med could put Atripla on the defensive

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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.

Business briefs: GSK, Vivus, Biogen Idec, Astellas, Myriad

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

Approval clears Boehringer to enter oncology space

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FDA's afatinib approval enables the drug maker set up shop in a new therapy space.

GSK gets 2 cancer pills approved, but a deeper question is left unanswered

GSK gets 2 cancer pills approved, but a deeper question is left unanswered

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GSK's newest cancer approvals highlight a problem that stalks progress with personalized medicines.

GSK adds competitor to COPD market

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The FDA approved the Breo/Ellipta combo, but analysts are wary about its potential to go beyond the COPD indication in the US.

Business briefs: Arena, Takeda, Teva, Cubist

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.

FDA streamlines patient access information

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A new FDA site gives patients a one-stop shop for commenting on pending regulations, finding clinical trials and navigating treatment options.

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