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Results For "US-FDA"

297 News Found

Medico Remedies to foray into ointment manufacturing segment
News | May 15, 2023

Medico Remedies to foray into ointment manufacturing segment

The facility will have a capacity to manufacture upto 3 million tubes monthly


Formosa Pharmaceuticals and AimMax Therapeutics announce NDA Submission to USFDA for APP13007
Drug Approval | May 08, 2023

Formosa Pharmaceuticals and AimMax Therapeutics announce NDA Submission to USFDA for APP13007

APP13007 is a novel aqueous nanosuspension formulation for the treatment of inflammation and pain following ocular surgery


Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA
Medical Device | May 05, 2023

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.


USFDA puts on hold Sun Pharma trials on dermatological drug
Drug Approval | May 04, 2023

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose


Ipca Laboratories gets 3 observations for Piparia, Silvassa unit
Drug Approval | April 27, 2023

Ipca Laboratories gets 3 observations for Piparia, Silvassa unit

The company will submit its comprehensive response on these observations to the US FDA within the stipulated time


USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility
Drug Approval | April 24, 2023

USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility

The USFDA had classified the inspection as "Official Action Indicated" (OAI).


Microbion gets US patent for the use of inhaled pravibismane for pulmonary infections
News | April 06, 2023

Microbion gets US patent for the use of inhaled pravibismane for pulmonary infections

Extends patent protection for Microbion's proprietary inhaled pravibismane for the treatment of pulmonary infections to 2039


GSK and SCYNEXIS announce agreement to commercialise and further develop Brexafemme
News | April 03, 2023

GSK and SCYNEXIS announce agreement to commercialise and further develop Brexafemme

SCYNEXIS will receive an upfront payment of $90 million with future performance-based milestone payments and tiered royalties


Granules India receives ANDA approval for Gabapentin Tablets
Drug Approval | March 30, 2023

Granules India receives ANDA approval for Gabapentin Tablets

Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults


Granules India inaugurates packaging facility in Virginia
Supply Chain | March 30, 2023

Granules India inaugurates packaging facility in Virginia

The facility is over 79,000 square feet and is equipped with packaging lines