Pfizer’s gene therapy for Haemophilia A receives positive topline results from Phase 3 Study
Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis
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Drug approvals
Alembic gains USFDA final approval for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg,…
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolixin Tablets, 1 mg, 2.5 mg, 5mg,…
Novo Nordisk’s Wegovy gets MHRA nod for use to lower heart risks
Semaglutide is the first weight loss drug approved in the UK as a preventative treatment for those with established cardiovascular…
Gland Pharma receives tentative USFDA approval for Latanoprostene Bunod Ophthalmic Solution
According to IQVIA, the product had US sales of approximately $ 153 million for the twelve months ended December 2023
ZIM Laboratories gains approval to market Azithromycin for Oral Suspension 200 mg/5ml (40 mg/ml) in…
Azithromycin Oral Suspension is differentiated in taste-masked suspension dosage. This is the first marketing authorisation for…
Zydus receives final US FDA nod for Valsartan Tablets
Valsartan tablets had annual sales of $149.5 mn in the United States (IQVIA MAT May 2024)
Zydus gets COFEPRIS nod to market Bhava to treat various cancers
Bhava, a Bevacizumab biosimilar and will be marketed in different strengths of 100 mg/4 ml and 400 mg/16 ml
Centaur launches chronic heart failure generic drug In the US
Introduces generic Ivabradine hydrochloride, expanding its US market presence
Glenmark Pharmaceuticals receives ANDA approval for Topiramate Capsules USP, 15 mg and 25 mg
The drug as been determined by the FDA to be bioequivalent and therapeutically equivalent to Topamax Capsules
Lupin receives tentative approval from U.S. FDA for Sodium Sulfate, Magnesium Sulfate, and Potassium…
The drug will be manufactured at Lupin’s Nagpur facility, India
Lupin receives approval from U.S. FDA for Topiramate Extended-Release Capsules
The company to market a generic equivalent of Trokendi XR Extended-Release Capsules
US FDA declines to approve Novo Nordisk’s weekly insulin
The regulator's decision follows its outside panel's vote against the use of the weekly insulin icodec, in patients with type 1…
Zydus gains final FDA nod for Sacubitril and Valsartan Tablets
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and…
Lupin gains tentative FDA approval for Empagliflozin, Linagliptin, Metformin Hydrochloride ER…
This product will be manufactured at Lupin’s Pithampur facility in India
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…
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…
Alembic Pharma announces US FDA tentative approval for Ivosidenib tablets 250 mg
The approved ANDA is therapeutically equivalent to the RLD product, Tibsovo Tablets, 250 mg, of Servier Pharmaceuticals
EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD: GlobalData
Dupixent shows promise for COPD, new treatment option reduces flare - ups and improves breathing
FDA approves Eli Lilly’s alzheimer’s drug
The drug is targeted at adults in the mild cognitive impairment or mild dementia stage