Insight on USFDA approval of new add-on drug, Nourianz (istradefylline), to treat off episodes in adults with Parkinson’s disease
The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s... Read More
Pharma brand acquisition case study: Amgen to acquire Celgene’s Otezla
Amgen announced today that it has entered into an agreement with Celgene Corporation in connection with its previously announced merger with Bristol-Myers... Read More
Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)
U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment... Read More
GSK grants exclusive technology license for Ebola vaccines to Sabin Vaccine Institute
GSK and the Sabin Vaccine Institute (Sabin), a non-profit organization, announced exclusive agreements for Sabin to advance the development of the prophylactic... Read More
Turalio: USFDA approval of first therapy for rare joint tumor
U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell... Read More
Case Study: The Mylan-Upjohn,Pfizer Merger
Pfizer, the world’s largest drugmaker, plans to combine its off-patent drug business and combine it with generic-drug maker Mylan. Pfizer shareholders would... Read More
Take a Self Competency Test in European Drug Regulatory Affairs
Posted on07 Aug 2019
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Effective regulatory strategic planning is a challenging as different regions and countries need to follow different regulatory requirements for Marketing Authorization Application... Read More