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1549 News Found

Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules
Drug Approval | August 22, 2023

Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules

Oteseconazole Capsules were found to be safe and more effective than fluconazole


Lupin receives approval from USFDA for Bromfenac Ophthalmic
News | August 20, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).


Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%
Drug Approval | August 17, 2023

Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%

Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace


Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
Drug Approval | August 16, 2023

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.


Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP
Drug Approval | August 16, 2023

Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).


Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma
Drug Approval | August 16, 2023

Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma

ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity


Tulasi Healthcare Introduces dTMS Therapy service for Treatment-Resistant Depression
Healthcare | August 16, 2023

Tulasi Healthcare Introduces dTMS Therapy service for Treatment-Resistant Depression

Deep Transcranial Magnetic Stimulation (dTMS) is a non-invasive brain stimulation technique approved by regulatory authorities, including the USFDA


Boehringer Ingelheim receives FDA approval for Senvelgo to treat diabetes in cat
Drug Approval | August 16, 2023

Boehringer Ingelheim receives FDA approval for Senvelgo to treat diabetes in cat

Senvelgo is the first liquid once-daily, orally administered prescription medication to improve glycemic control in cats with diabetes mellitus


Eugia Pharma receives USFDA Approval for Icatibant Injection
Drug Approval | August 16, 2023

Eugia Pharma receives USFDA Approval for Icatibant Injection

This is the 166th ANDA out of Eugia Pharma Speciality Group facilities