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Lupin receives US FDA’s tentative approval for Empagliflozin and Linagliptin Tablets
expresspharma
July 24, 2020
Empagliflozin and Linagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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ChemWerth Files its 500th Drug Master File with FDA
contractpharma
July 24, 2020
API supplier supports both large and small finished dosage companies worldwide.
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FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products
expresspharma
July 23, 2020
The US FDA is revising the guidance to reflect that FDA generally intends to exercise enforcement discretion with respect to IND and premarket approval requirements for certain HCT/Ps through May 2021.
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GI Supply Receives FDA Clearance of First Submucosal Lifting Agent in Pre-filled Syringe
americanpharmaceuticalreview
July 22, 2020
GI Supply announced the FDA clearance of EverLift™ Submucosal Lifting Agent, a new device for the lift of polyps, adenomas, early-stage cancers and other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic devices.
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FDA accepts Acadia’s application for dementia drug Nuplazid
pharmaceutical-technology
July 22, 2020
The US Food and Drug Administration (FDA) has accepted Acadia Pharmaceuticals’ supplemental new drug application (sNDA) for an antipsychotic drug, named Nuplazid (pimavanserin) to treat hallucinations and delusions in dementia patients.
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Over 158 applications for generic products pending with US FDA for approval: Lupin
expresspharma
July 22, 2020
Sharing information with company's shareholders, Lupin MD Nilesh Gupta and CEO Vinita Gupta said the company's US business stabilised last fiscal and saw an increase of 5 per cent on the back of products like Levothyroxine and Oseltamivir.
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Six people tests coronavirus positive in Maha FDA
expresspharma
July 22, 2020
Six staff of the Maharashtra Food and Drug Administration’s (FDA) have tested coronavirus positive.
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Assembly Biosciences Announces FDA Fast Track Designation for Chronic Hepatitis B Virus Treatment
americanpharmaceuticalreview
July 21, 2020
Assembly Biosciences announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H2158 (2158) for the treatment of patients with chronic HBV infection.
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Brilinta Granted FDA Priority Review
americanpharmaceuticalreview
July 21, 2020
AstraZeneca announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) for the reduction of subsequent stroke in patients ...
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Mylan, Fujifilm Kyowa Kirin Biologics Announce FDA Approval of Hulio
americanpharmaceuticalreview
July 21, 2020
Mylan and Fujifilm Kyowa Kirin Biologics announced the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp), a biosimilar to AbbVie's Humira® (adalimumab).