The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
This certification will open new markets for the Kwality Pharma
The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru
Jemperli plus chemotherapy is the only immuno-oncology-based treatment to show statistically significant and clinically meaningful OS benefit in the overall population
This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure
Biocon Biologics remains committed to global standards of quality and compliance
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A
Wockhardt plans to launch Miqnaf in the Indian market in coming few months
DOVBLERON marks the 13th addition to Innovent’s commercial portfolio
MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria
Expects to unlock further opportunities in the Moldovan market, contributing anticipated sales of $300,000 in 2025 and approximately $700,000–$800,000 in 2026
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