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drug approval

This page shows the latest drug approval news and features for those working in and with pharma, biotech and healthcare.

FDA clears first-line use for J&J’s myeloma drug Darzalex

FDA clears first-line use for J&J’s myeloma drug Darzalex

FDA clears first-line use for J&J’ s myeloma drug Darzalex. Frontline approval for Janssen's Darzalex a milestone in march towards blockbuster status. ... Johnson &Johnson’s efforts to position Darzalex earlier in the treatment pathway for multiple

Latest news

  • Pfizer claims rapid FDA nod for Lorbrena Pfizer claims rapid FDA nod for Lorbrena

    The US regulatory body awarded the drug with an accelerated approval, acknowledging successful overall response rates of 48%. ... It’s the third approval in three months for Pfizer’s oncology unit after having seen success with PARP inhibitor

  • Symkevi approval in Europe helps Vertex expand CF treatment Symkevi approval in Europe helps Vertex expand CF treatment

    Vertex has announced the European Union approval of its new two-drug combination Symkevi (tezacaftor/ivacaftor), which helps expand treatment to a far larger number of cystic fibrosis (CF) patients. ... over the next 10 years from Orkambi, Kalydeco and

  • GSK’s says depot HIV injection works over three years GSK’s says depot HIV injection works over three years

    Earlier this year, GSK won approval for oral two-drug regimen Juluca – based on integrase inhibitor Tivicay (dolutegravir) and rilpivirine – that aims to provide effective control of HIV with a single ... GSK says it remains on track to file for

  • Roche gets wider approval for haemophilia drug Hemlibra Roche gets wider approval for haemophilia drug Hemlibra

    Roche gets wider approval for haemophilia drug Hemlibra. Approved to treat bleeding episodes in patients without inhibitors. ... Hemlibra (eculizumab) was cleared for use in patients with inhibitors last year, and is now the only FDA-approved drug for

  • Novartis files for approval of MS drug in EU, US Novartis files for approval of MS drug in EU, US

    Novartis files for approval of MS drug in EU, US. Siponimod could achieve blockbuster status if approved, says analysts. ... Novartis wants to get the new orally-active drug to patients as quickly as possible so is using a priority review voucher it

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Latest Intelligence

  • Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe

    Alnylam was also forced to abandon one of its first pipeline drugs, revusiran, after it was linked to deaths in trials, but persisted, developing a safer and more potent drug delivery ... platform. Led by founder and CEO John Maraganore, Alynlam finally

  • China: AstraZeneca’s new engine for growth and innovation China: AstraZeneca’s new engine for growth and innovation

    In March 2017, AZ’s targeted lung cancer drug Tagrisso was one of the first medicines to gain approval through the Chinese Food and Drug Administration (CFDA) ’s Priority Review pathway, ... This means the out-of-pocket cost for healthcare has fallen,

  • The rise of real-world evidence The rise of real-world evidence

    Using real-world evidence. RWE has distinct applications pre- and post-approval. Before a drug comes to market, sponsors use the resource to evaluate unmet needs, identify subpopulations of patients and ... Once a therapy wins approval, companies turn to

  • Finding the patient voice Finding the patient voice

    probability of the drug getting approval. ... Mr Whitley went on to volunteer at an NGO, working with pharma companies to make drug trials simpler for patients.

  • A catalyst for change A catalyst for change

    This was considered a significant step in the internationalisation of the Chinese drug approval process. ... The Policy was a groundbreaking comprehensive instrument that targeted several key issues and fundamentally restructured the entire drug approval

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Latest appointments

  • Anthony Zook resigns as Vivus CEO Anthony Zook resigns as Vivus CEO

    shareholders became unhappy with the way Vivus handled the launch of its obesity drug Qsymia (phentermine/ topiramat). ... Pharmaceuticals. Vivus also failed in a bid to win approval for the drug in Europe.

  • CytomX makes senior changes following Pfizer deal CytomX makes senior changes following Pfizer deal

    During his time at Affymax, Dr Polu headed several areas, including clinical sciences, clinical operations and drug safety/pharmacovigilance. ... He was also one of the key figures behind the development and approval of Affymax' first drug Omontys

  • Kite Pharma appoints Zelboraf scientist as CMO Kite Pharma appoints Zelboraf scientist as CMO

    At Plexxikon, he also led the filing of eight investigational New Drug Applications in cancer. ... Dr Nolop's vast experience in drug development from conception to approval will be instrumental to advancing Kite's eACT products through multi-center

  • Sweden’s Tomas Salmonson to chair EMA’s CHMP Sweden’s Tomas Salmonson to chair EMA’s CHMP

    Commenting on his election Salmonson said: “ The regulation of medicines has become much more proactive over the past few years, and we must embrace the tools we have to shape drug ... development pre- and post-approval, for example by providing

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