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6614 News Found

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg
Drug Approval | August 21, 2024

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg

This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India


Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program
News | August 21, 2024

Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program

Rad-Sure blood irradiation indicators are FDA 510 (k) cleared medical devices that offer positive visual verification of irradiation at the minimum specified dose


Sequent Scientific receives WHO prequalification approval for Albendazole API
News | August 20, 2024

Sequent Scientific receives WHO prequalification approval for Albendazole API

This is in partnership with Mepro Pharmaceuticals which have successfully developed and commercialised the Albendazole Chewable formulation


Granules India receives ANDA approval for Glycopyrrolate Oral Solution
Drug Approval | August 20, 2024

Granules India receives ANDA approval for Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients


EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
News | August 19, 2024

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile


Aptar’s nasal unidose system delivers FDA-approved neffy
News | August 19, 2024

Aptar’s nasal unidose system delivers FDA-approved neffy

This marks the first regulatory approval worldwide for nasally-delivered epinephrine


Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP
News | August 19, 2024

Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP

This addition highlights our commitment to meeting market needs and providing high-quality over the-counter solutions for our customers


Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer
Drug Approval | August 17, 2024

Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer

Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone


Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution
Drug Approval | August 17, 2024

Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.