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1083 News Found

Sai Life Sciences, Agility Life Sciences, and Centrix Pharma Solutions launch Integrated CMC Partnership to accelerate drug development
News | October 08, 2025

Sai Life Sciences, Agility Life Sciences, and Centrix Pharma Solutions launch Integrated CMC Partnership to accelerate drug development

The collaboration combines the extensive CMC expertise of Sai Life Sciences in API development, Agility Life Sciences in formulation development, and Centrix Pharma Solutions in drug product development and clinical manufacturing


PromoCell launches custom GMP cell culture media to power next-gen cell and gene therapies
Biotech | October 07, 2025

PromoCell launches custom GMP cell culture media to power next-gen cell and gene therapies

New offering to debut at the 32nd ESGCT Congress, October 7–10, 2025, in Seville, Spain


Leqembi wins NMPA nod for once-monthly IV dosing in early Alzheimer’s patients
News | September 30, 2025

Leqembi wins NMPA nod for once-monthly IV dosing in early Alzheimer’s patients

LEQEMBI was initially approved in China in January 2024 for the treatment of Alzheimer’s disease in patients with mild cognitive impairment


FDA approves Eli Lilly’s Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer
Drug Approval | September 29, 2025

FDA approves Eli Lilly’s Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor


Air Liquide bags contract in Spain to care for patients living with respiratory conditions at home
Healthcare | September 27, 2025

Air Liquide bags contract in Spain to care for patients living with respiratory conditions at home

Air Liquide will provide care for people living with respiratory diseases such as chronic obstructive pulmonary disease (COPD) and sleep apnea


Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets
Drug Approval | September 25, 2025

Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg


Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'
News | September 24, 2025

Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'

Prolia is a prescription medicine used to treat osteoporosis in women


AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1
Drug Approval | September 24, 2025

AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population


Roche's Giredestrant combination meets phase III endpoints in advanced breast cancer
Clinical Trials | September 23, 2025

Roche's Giredestrant combination meets phase III endpoints in advanced breast cancer

Importantly, the combination of giredestrant and everolimus was well tolerated