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–$800,000 in 2026
Cenexi is committed to working closely with the ANSM to address the observations
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
GEMTESA is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
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