Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.

USFDA completes inspection of Lupin's Dabhasa facility with no observations

The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations

Dr. Reddy's launches drug-free migraine management device Nerivio in Europe

Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer

Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2

NATCO Pharma receives warning letter from USFDA for facility in Kothur, Telangana

The company will respond to the Warning Letter within the stipulated timelines

Lupin launches first generic version of Oracea in US

Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients

Shivalik Rasayan’s API facility gets 7 observations from USFDA

These observations are procedural in nature and will be responded within the stipulated time

Eugia Steriles gets 3 observations from USFDA for injectable facility

The observations are procedural in nature and will be responded to within the stipulated time

Gland Pharma receives USFDA approval for Eribulin Mesylate Injection

The Product is expected to be the first generic approval on the market