Pages

▼
Showing posts with label USFDA Approval drugs. Show all posts
Showing posts with label USFDA Approval drugs. Show all posts

Bayer Receives FDA Approval for Kovaltry

›
  Bayer Receives FDA Approval for Kovaltry® for the Treatment of Children and Adults with Hemophilia A The U.S. Food and Drug Admin...

Aurobindo Pharma gains on USFDA nod for Naproxen Sodium Tablets

›
Aurobindo Pharma has received final approval from the US Food & Drug Administration to manufacture and market   Naproxen Sodium ...

Orchid Pharma gets USFDA nod for Parkinson's drug

›
Orchid Pharma   has announced it has received final approval from the US drug regulator to its Rasagiline Tablets 0.5 mg and 1 mg for tr...

FDA Approves New Kyprolis Combination Therapy

›
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis ® ...

Eli Lilly submits NDA TO FDA for Baricitinib

›
Eli Lilly and Company and Incyte Corporation announced that Lilly has submitted a new drug application (NDA) to the U.S. Food and Drug Admi...

U.S. Food and Drug Administration Approves Humulin R U-500 KwikPen

›
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Humulin ® R U-500 KwikPen ® (insulin human injection...

U.S. and European Regulators Accept Venetoclax for Chronic Lymphocytic Leukemia

›
AbbVie announced that the U.S. Food and Drug Administration (FDA) accepted AbbVie's New Drug Application (NDA) granting priority revi...

Novartis receives two new FDA approvals

›
Novartis announced that the US Food and Drug Administration (FDA) has approved Cosentyx ® (secukinumab) for the treatment of two new indi...

Glenmark gets tentative FDA approval for generic version of Multaq

›
Glenmark Pharmaceuticals said it has received a tentative nod from US Food and Drug Administration for generic version of Cardiac drug Mult...

ZURAMPIC approved by US FDA for patients with gout

›
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved ZURAMPIC® (lesinurad) 200mg tablets in combination with ...

Mylan Launches Generic Zyvox Tablets

›
Mylan N.V. announced the U.S. launch of Linezolid Tablets, 600 mg, which is the generic version of Pfizer's Zyvox ® Tablets. Mylan re...

FDA Approves Expanded Indication of KEYTRUDA in Melanoma

›
Merck announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for KEYTRUDA ® (pembrolizumab),...

FDA Approves Expanded Age Indication for GARDASIL 9 in Males

›
Merck announced that the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GARDASIL ® 9 (Human Papillomavirus...

FDA grants Alecensa accelerated approval for people with a specific type of lung cancer

›
Roche announced that the US Food and Drug Administration (FDA) granted accelerated approval to Alecensa® (alectinib) for the treatment of p...

FDA ACCEPT NDA For VIEKIRA PAK

›
AbbVie   a global biopharmaceutical company, announced its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administr...

TAGRISSO approved by the US FDA

›
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved TAGRISSO™ (AZD9291) 80mg once-daily tablets for the trea...

FDA approves Cotellic in combination with Zelboraf

›
Roche announced that the U.S. Food and Drug Administration (FDA) approved Cotellic (cobimetinib) for the treatment of people with BRAF V6...

Nucala receives approval from US FDA

›
GlaxoSmithKline plc received approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nuc...

FDA Advisory Committee recommends the approval of lesinurad for gout patients

›
AstraZeneca today announced that the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommen...

Merck Receives Breakthrough Therapy Designation from USFDA

›
Merck announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA ® ...