Alembic gets US FDA nod for Bromfenac Ophthalmic Solution, 0.07 per cent
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolensa Ophthalmic Solution, 0.07 per…
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US FDA
J&J receives full approval from US FDA and European Commission for SIRTURO
With the FDA’s approval, label restrictions that were included when the medicine was granted accelerated approval in the US in…
FDA approves Genentech’s Vabysmo Prefilled Syringe (PFS) for three leading causes of vision loss
Vabysmo PFS is reportedly the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal…
Revised Schedule M audits to test will, skill of regulators and regulated
As the US FDA raises quality expectations, investigations into its inspection practices are being closely watched by biopharma…
US FDA puts Zentalis’ cancer drug studies on partial hold after patient deaths
The regulator's decision comes after two patients in the ovarian cancer study died due to presumed blood-related infection…
US FDA expands approval to GSK’s Arexvy for adults aged 50-59, at increased risk
The RSV vaccine adjuvanted is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared…
Lupin receives tentative approval from U.S. FDA for Letermovir tablets
The generic equivalent of Prevymis, will be manufactured at Lupin’s Nagpur facility in India
Lupin has announced that it has…
Alembic announces USFDA approval for Sacubitril and Valsartan tablets
Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in…
Maiva Pharma raises Rs 1,000 cr from Morgan Stanley, India Life Sciences Fund
The proceeds will be used to set up a new manufacturing facility near Hosur with capabilities in sterile dosage forms
Granules India gets ANDA approval for Colchicine capsules
Colchicine Capsules are indicated for prophylaxis of gout flares in adults