Please login to the form below

Not currently logged in
Email:
Password:

drug approval

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

Aimmune wins over ICER for peanut allergy product

Aimmune wins over ICER for peanut allergy product

Analysts predict blockbuster status for first-in-class. Aimmune is still a few months away from a potential US approval of its peanut allergy drug AR-101, but already has a ... Moreover, the analysis doesn’t include the most up-to-date phase 3 results

Latest news

  • Keytruda begins pursuit of rivals in small cell lung cancer Keytruda begins pursuit of rivals in small cell lung cancer

    Set for competition with Opdivo. Merck &Co. has gained approval for Keytruda for use in third line treatment of small cell lung cancer (SCLC). ... The drug’s approval was fast-tracked by the FDA following the results of its KEYNOTE-158 and KEYNOTE-028

  • Amarin up as FDA speeds Vascepa’s cardiovascular claim review Amarin up as FDA speeds Vascepa’s cardiovascular claim review

    Shares in the Ireland-domiciled company closed up almost 12% yesterday after the priority review was announced, setting up a possible approval of the additional indication for the drug in September, ... the first drug in line for approval in the large

  • Lilly claims cluster headache first for CGRP drug Emgality Lilly claims cluster headache first for CGRP drug Emgality

    Competition fierce in new class. Eli Lilly has pushed its nose in front of its rivals in the CGRP inhibitor market with the first FDA approval of a drug in the ... Emgality’s approval is based on a trial that compared the drug to placebo in 106

  • A first for Bluebird and Europe as gene therapy Zynteglo approved A first for Bluebird and Europe as gene therapy Zynteglo approved

    Will product be priced over $1m? Bluebird Bio is celebrating its first ever drug approval, with the European Commission yesterday granting conditional marketing authorisation for its groundbreaking gene therapy Zynteglo (autologous ... The approval comes

  • Lilly scores FDA okay for Cyramza in liver cancer Lilly scores FDA okay for Cyramza in liver cancer

    Approved as second line treatment after Bayer’s Nexavar. Eli Lilly has added a fifth indication for its cancer drug Cyramza, getting an FDA approval for hepatocellular carcinoma (HCC) that expresses ... NSCLC, which could be the drug’s sixth

More from news
Approximately 6 fully matching, plus 873 partially matching documents found.

Latest Intelligence

  • Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019 Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019

    The Novartis subsidiary sought approval via both Orphan Drug and Breakthrough Therapy designations. ... In the EU and Japan, approval of the drug is pending, following acceptance of regulatory filings in 2018.

  • Where next in Alzheimer’s disease R&D? Where next in Alzheimer’s disease R&D?

    Yet none of these programmes has yielded a drug approval, making Alzheimer’s R&D perhaps the least effective use of money in pharma or any other industry. ... AC Immune and its partners are far from the only drug developers to target tau.

  • Drug launches to watch in 2019 Drug launches to watch in 2019

    However the company, like many others, is at the mercy of the US government shutdown, which means many FDA staff are on unpaid leave, and threatens drug approval timelines if it ... Erleada (apalutamide) is the first drug to be cleared on the strength of

  • China’s clinical trial shake-up China’s clinical trial shake-up

    Chinese authorities have supported the local R&D boom and made the country more attractive for overseas companies by overhauling clinical trial and drug approval processes. ... A drug control institute or third-party laboratory tests drug samples to

  • 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

More from intelligence
Approximately 0 fully matching, plus 35 partially matching documents found.

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

More from appointments
Approximately 0 fully matching, plus 4 partially matching documents found.

Latest from PMHub

More from PMHub
Approximately 1 fully matching, plus 4 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
emotive.

emotive. is an award-winning healthcare communications agency working with leading global and EMEA companies in life sciences including medical device...

Latest intelligence

The social dilemma: is it time for pharma to join the party?
Chris Ross explores why social media still isn’t trending for pharma, and how it can join in the fun...
MIT reveals new pill to deliver insulin
A new MIT research project, sponsored by Novo Nordisk, is aiming to deliver insulin orally with a pill that releases medicine in the stomach lining. Dina Patel interviews the team...
Fearless Girl cover
25 Women Leaders in UK Healthcare
Women trailblazers helping to shape the future of healthcare (Part 1)...

Infographics