FDA approves Roche’s Vabysmo PFS for three leading causes of vision loss

Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness

Alembic announces USFDA tentative approval for Bosutinib Tablets, 100 mg and 500 mg

Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg

Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients

Jubilant Ingrevia receives EIR from USFDA for Unit-1 at Bharuch

This existing GMP compliant facility, located at Bharuch (Unit-1) with ongoing expansion part of the company's strategic capex initiative

Eugia SEZ’s injectable facility gets EIR from USFDA

The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated

Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA

This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies

Lupin receives EIR from US FDA for its Somerset manufacturing facility

The facility was inspected from May 7 to May 17, 2024

Cipla gets 6 observations from USFDA for Goa facility

The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time

Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC

Second FDA approval for KRAZATI - reinforcing its potential across tumor types

Roche receives FDA clearance on its digital pathology solution for diagnostic use

This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions