Approval marks the first all-oral, once-daily, fixed-duration Bruton’s tyrosine kinase (BTK) inhibitor-based regimen for first-line treatment of CLL The Janssen Pharmaceutical Companies of Johnson &…
Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance…
RINVOQ (upadacitinib) is now approved by the European Commission for the treatment of adult patients with moderately to severely active ulcerative colitis who have had…
SOD1-ALS is a rare genetic form of ALS that affects approximately 330 people in the U.S.,1 it is progressive, leads to the loss of everyday functions…
First and only long-acting C5 complement inhibitor showed early effect anddemonstrated clinical improvement in activities of daily living Ultomiris (ravulizumab) has been recommended for marketing authorisation…
— If Granted by the European Commission, Veklury will Become the Only Direct-Acting Antiviral with Full Marketing Authorization in the EU — Gilead Sciences, Inc.…
Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study Proposed Hyrimoz® HCF would help expand access to medicine for patients with…
The submission is based on two pivotal Phase 3 studies evaluating atogepant in adult patients with episodic and chronic migraine If approved, atogepant would be…
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused…
New Prescribing Authority Could Improve Access for Some Patients at High Risk for Severe COVID-19 Today, the U.S. Food and Drug Administration revised the Emergency Use…
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) announced today that…
Novel GPRC5DxCD3 Bispecific Antibody Receives Breakthrough Therapy Designation Based Upon Results from the Phase 1/2 MonumenTAL-1 Study The Janssen Pharmaceutical Companies of Johnson & Johnson…