Case Study: 505(b)(2) filing pathway – USFDA approval of Vumerity
Biogen, global biotechnology company, and Alkermes, global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved Vumerity (diroximel fumarate),... Read More
US FDA places partial hold on Novartis’ AVXS-101 intrathecal study
USFDA placed a partial hold on clinical trials for intrathecal administration of AVXS-101. The announcement follows an AveXis communication to health authorities... Read More
Insighht on USFDA approval of Trikafta
Vertex Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA). This is a landmark approval where Vertex’s Trikafta earned this... Read More
US FDA issued warning letter to Glenmark for Baddi plant
Posted on21 Oct 2019
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The US Food and Drug Administration has issued a warning letter to Glenmark Pharmaceutical Ltd’s manufacturing plant in Baddi, Himachal Pradesh, the company said... Read More
New Drug Approval Case Study: USFDA approval of Galderma’s Aklief cream
US Food and Drug Administration (FDA) approved Galderma’s Aklief (trifarotene) cream, 0.005% for the topical treatment of acne. Aklief Cream is the... Read More
Biocon, Mylan launch first insulin glargine biosimilar, Semglee in Australia
Biocon Ltd and Mylan N.V. announced the launch of Semglee (insulin glargine solution for injection 100 IU/mL in a 3mL pre-filled pen),... Read More
USFDA approval of Rituxan, in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients 2 years of age and older
Roche announced that the US Food and Drug Administration (FDA) has approved Rituxan (rituximab), in combination with glucocorticoids, for the treatment of... Read More
AstraZeneca to launch QTERN in India with DCGI marketing authorization approval
Posted on27 Sep 2019
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AstraZeneca Pharma has received import and market permission in Form 45 (marketing authorization) for QTERN (fixed dose combination of dapagliflozin 10mg +... Read More
FDA approved Rybelsus (semaglutide): first oral GLP-1 treatment for type 2 diabetes
Posted on25 Sep 2019
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The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with... Read More
Bayer received EU marketing authorization for the precision oncology treatment Vitrakvi (larotrectinib)
Bayer announced that the European Commission has granted marketing authorization in the European Union (EU) for the precision oncology treatment Vitrakvi (larotrectinib).... Read More