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1569 News Found

Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets
Drug Approval | October 07, 2022

Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.


Zydus receives USFDA tentative approval for Amantadine Extended-Release capsules
Drug Approval | October 05, 2022

Zydus receives USFDA tentative approval for Amantadine Extended-Release capsules

Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data


Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets
Drug Approval | October 04, 2022

Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency


Zydus receives final approval from the USFDA for Sildenafil for Oral Suspension
Drug Approval | October 01, 2022

Zydus receives final approval from the USFDA for Sildenafil for Oral Suspension

Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).


USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility
Drug Approval | September 30, 2022

USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility

The company will address the observations within a stipulated timeline working with the regulators


Emmes acquires Clinical Edge
News | September 30, 2022

Emmes acquires Clinical Edge

The combination of Optym, Emmes' ophthalmology certification unit, and Clinical Edge will make the organization a leader in ophthalmic certification and training services


NIHR addresses research in surgery in India
News | September 28, 2022

NIHR addresses research in surgery in India

The two-day meeting in the city was organized in collaboration with the University of Birmingham, Christian Medical College Ludhiana, and Birmingham Clinical Trials Unit


Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses


Novartis unveils new focused strategy
News | September 27, 2022

Novartis unveils new focused strategy

Transformation to pure-play Innovative Medicines company nears completion


Aptar Pharma collaborates with Fluidda
News | September 25, 2022

Aptar Pharma collaborates with Fluidda

The companies will leverage their respective proprietary technology platforms