Tag Archives: FDA

FDA Approval Announced by Lupin for Fluoxetine Tablets USP

Headline


U.S. FDA Issue EIR for Lupin’s Pithampur Unit-3 (Indore)

Headline


Process Analytical Technology For Upstream Bioprocessing

Featured Article


Development and Implementation of Process Analytical Technology (PAT) Systems in the Biopharmaceutical Sector – Challenges and Returns

Magazine Article


Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Magazine Article


New Paradigm of Building Quality during Manufacture – Challenges with Biological Products

Magazine Article


Process Analytical Technology for Upstream Bioprocessing

Magazine Article


Is automation the disruption pharma R&D needs?

Magazine Article


FDA Approves Genentech’s OCREVUS™ (Ocrelizumab) For Relapsing and Primary Progressive Forms of Multiple Sclerosis

Headline


US FDA approves drug to treat Parkinson’s disease

Headline


FDA Approves Merck’s KEYTRUDA® (pembrolizumab)

Headline


WuXi AppTec Lab Testing Division’s Bioanalytical Service Unit Passed FDA Inspection

Headline


FDA Accepts BLA for Mylan & Biocon’s Proposed Biosimilar Pegfilgrastim for Review

Headline


FDA approve Novo Nordisk’s Xultophy® 100/3.6

Headline


FDA grants fast track designation for development of Eisai’s BACE Inhibitor, for early Alzheimer’s

Headline


Novo Nordisk submit application to FDA for trials in the label for Tresiba®

Headline


FDA approve Amgen’s AMJEVITA™

Headline


FDA approve Cipla’s ANDA for Darifenacin Extended-Release Tablets

Headline


FDA grant 510(k) clearance for Companion Medical’s InPen® system

Headline


Excipient Variability and its Implications with Respect to Drug Quality from a Regulator’s perspective

Magazine Article


AstraZeneca & Eli Lilly receive FDA Fast Track designation for the development program in Alzheimer’s disease for AZD3293

Headline


WuXi announce Jinshan Shanghai Facility has successfully passed FDA general GMP and Pre-Approval Inspection

Headline


FDA confirm there is sufficient data to support Eisai’s novel BACE inhibitor

Headline


FDA approve Natco’s generic Tamiflu®

Headline


FDA approve manufacture and market of Auroqindo’s Linezolid Injection

Headline


FDA approve Merck’s Keytruda®

Headline


Sun Pharma subsidiary announce FDA approval for ANDA version of Glumetza®

Headline


Sun Pharma receive FDA approval for generic Rosuvastatin tablets

Headline


FDA approve Dr Reddys’ Omeprazole and Sodium bicarbonate capsules in US

Headline


Kyowa Hakko Kirin’s investigational recombinant fully human monoclonal IgG1 antibody receives Breakthrough Therapy Designation from FDA

Headline


Mitsubishi Tanabe NDA submitted to FDA for treatment of ALS

Headline


FDA approve additional indication for Eisai’s Lenvima®

Headline


Aurobindo get approval from FDA to manufacture and market Amlodipine and Valasartan tabs

Headline


Lupin receives FDA approval for Fyavolv ™ Tablets

Headline


FDA approve Aurobindo’s Polymyxin B for Injection USP

Headline


Takeda & Lundbeck receive letter regarding sNDA from FDA

Headline


Sartorius Stedim BioOutsource Contract Testing Facility in Glasgow successfully passed FDA inspection

Headline


Takeda and Lundbeck get support from PDAC for Brintellix

Headline


Dr Reddy’s US Subsidiary receives FDA approval for Sernivo

Headline


FDA grant tentative approval for Dr Reddy’s Labs’ Zenavod

Headline


FDA accepts for review sNDA for Eisai’s Lenvatinib

Headline


Chugai announce Genentech’s Anti Cancer agent receives FDA approval

Headline


FDA grant Sun Pharma approval of Imatinib Mesylate tablets 100mg and 400mg

Headline


Takeda announce FDA have approved NINLARO®

Headline


Dr Reddy’s issue statement after receiving FDA letter

Headline


USP Current Perspective on Depyrogenation and Endotoxin Indicators

Magazine Article


Daiichi Sankyo announce FDA have granted Breakthrough Therapy Designation to its investigational oral CSF-1R inhibitor Pexidartinib

Headline


FDA approve Opdivo

Headline


FDA approve Alkermes’ ARISTADA™

Headline


Takeda granted Priority review for NDA of Ixazomib, by FDA

Headline


Takeda & Lundbeck announce that FDA accept sNDA for Brintellix

Headline


Catalent’s OPTISHELL™ Technology is delivery platform for Opko Health’s new chronic kidney disease treatment

Headline


Takeda submit NDA for Ixazomib

Headline


Otsuka and Lundbeck announce FDA approve REXULTI®

Headline


FDA approve Cystic Fibrosis drug, Orkambi

Headline


FDA approve Beigene’s IND

Headline


FDA Approve Eisai’s antiepileptic agent Fycompa®

Headline


FDA approve Nivolumab (Opdivo)

Headline


FDA review Novartis’ investigational LCZ696

Headline


Lupin gets FDA Approval for Vancocin® Capsules

Headline


Otsuka and Lundbeck announce that Labeling Update of Abilify Maintena approved by FDA

Headline


FDA approve Ranbaxy’s Fenofibrate Capsules

Headline


TWi Pharmaceuticals Receives FDA Approval for Alzheimer’s drug

Headline


WuXi’s Partner TaiMed Biologics, receives Orphan Drug Designation for Ibalizumab

Headline


WuXi Facility Passes FDA Inspection for Manufacture of API

Headline


Takeda gets FDA nod for multiple myeloma drug

Headline


Raman Spectral Library for Counterfeit Detection

Magazine Article


Pharmaceutical Excipients: Part 2 – Excipient Composition and Performance

Magazine Article


WuXi PharmaTech Toxicology Facility in Suzhou Passes FDA Inspection

Headline


Granules India’s Paracetamol API Facility completes U.S. FDA Inspection

Headline


Security of supply in an uncertain environment

Headline


Meaningful Metrics for the Microbiology Laboratory

Magazine Article


Pharmaceutical Excipients: Part 1 – Excipient Variability: Sources, Importance and Potential Impact

Magazine Article


FDA trains Indian market to boost exports

Headline


Takeda drug gets FDA nod for new biologic therapy

Headline


‘Sun’s import ban response lacks enough action’

Headline


FDA to India: Regulatory compliance a must

Headline


Dr Reddy’s launches Eszopiclone tablets in US

Headline


FDA Approves Ibalizumab Manufactured by WuXi PharmaTech

Headline


Novartis gains FDA approval for Zykadia(TM)

Headline


Dr. Reddy’s launches Eszopiclone tablets in US

Headline


SI to acquire antioxidants, ibuprofen, propofol business

Headline


TriReme enrols patients for drug-coated Chocolate PTA balloon

Headline


Portable Raman Instruments: Putting the Power of the Lab in Your Hand

Magazine Article


Natco wins patent dispute case against Teva

Headline


Shire biologics facility gets FDA clearance

Headline


The FDA Drug Product Application Review Process: Microbiological Considerations

Magazine Article


Improved Process Understanding and End-Point Determination of High Shear Wet Granulation Process Using In-Line NIR at Different Scales

Magazine Article


TaiGen and R-Pharm to co-develop antibiotic

Headline


Risk-Based Sampling Strategies for Bacterial Endotoxin Testing

Magazine Article


Continuous Processing – to engage or not to engage?

Magazine Article


Digital Channels and the Counterfeit Prescription Drug Market: From Supply Chain to Customer

Magazine Article


FDA to add 10 new drug inspectors in China

Headline


Mundipharma and Shionogi tie up for pain treatment in Japan

Headline


Granules India acquires Auctus Pharma for $20 million

Headline


GEA Pharma Systems’ continuous process technology supports AstraZeneca’s further investments in R&D

Headline


Merck Millipore introduces the first Online Original Manufacturer Tracking Tool

Headline


Managing Successful Microbiological Investigations

Magazine Article


Dr. Reddy’s Laboratories will rollout Werum’s PAS-X MES in only five months

Headline


© 2019 biopharma-asia.com. All rights reserved. Privacy Policy