Updates on Olumiant (baricitinib) FDA review for atopic dermatitis

28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...

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Incyte provides update on parsaclisib and MCLA-145

25 January 2022 - Incyte today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of ...

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Genentech’s Evrysdi (risdiplam) granted FDA priority review for treatment of presymptomatic babies under 2 months of age with spinal muscular atrophy

24 January 2022 - Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi for at least ...

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Merck provides U.S. and Japan regulatory update for gefapixant

24 January 2022 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s New Drug ...

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Omeros confirms submission of response to FDA regarding the BLA for narsoplimab in the treatment of HSCT-TMA

19 January 2022 - Omeros Corporation today confirmed that earlier this month the company submitted to the U.S. FDA its response ...

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FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC

19 January 2022 - Regulatory filing recently submitted in the European Union. ...

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CANbridge Pharmaceuticals CAN108 new drug application for Alagille syndrome accepted by China’s National Medical Products Administration

17 January 2022 - Priority review expected to be granted. ...

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bluebird provides update on FDA review timelines for betibeglogene autotemcel for beta thalasszemia and elivaldogene autotemcel for cerebral adrenoleukodystrophy

18 January 2022 - FDA PDUFA goal dates for both therapies extended by three months. ...

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Enhertu granted priority review in the U.S. for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen

17 January 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis ...

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GSK and Vir submit emergency use authorisation application to FDA for intramuscular administration of sotrovimab for the early treatment of COVID-19

13 January 2022 - Submission follows COMET-TAIL Phase 3 data demonstrating that intramuscular administration of sotrovimab was non-inferior and offered ...

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The US FDA issues a complete response letter for the biologics license application for insulin aspart

7 January 2022 - The U.S. FDA has issued a complete response letter for the biologics license application for insulin ...

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Mitsubishi Tanabe Pharma America announces FDA acceptance of new drug application for oral edaravone formulation for the treatment of ALS

12 January 2022 - Mitsubishi Tanabe Pharma America today announced the U.S. FDA has accepted the new drug application for an ...

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EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19

10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...

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AbbVie submits applications for upadacitinib (Rinvoq) in non-radiographic axial spondyloarthritis to U.S. FDA and EMA

7 January 2022 - Submissions supported by Phase 3 study in which upadacitinib (Rinvoq) demonstrated significant improvements in signs and symptoms ...

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Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS

4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...

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