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…
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Drug approvals
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
Signet Therapeutics announces IND approval by the FDA for world’s first targeted therapy for DGC
Sigx1094 is also reportedly the first of a series of pipeline projects that was discovered by AI and validated by organoid disease…
Alembic Pharma announces USFDA Tentative Approval for Bosutinib Tablets, 100 mg and 500 mg
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD)
Alzheimer’s drug Leqembi launched by Eisai, Biogen in China
China is the third country to launch LEQEMBI following the US and Japan
Lupin receives tentative approval for Olopatadine Hydrochloride Ophthalmic Solution
The drug is a generic equivalent of Pataday Once Daily Relief, 0.7 per cent (OTC)
FDA approval of CAPVAXIVE will enhance protection against pneumococcal disease in older adults:…
This is the first pneumococcal vaccine that is specifically designed to protect against serotypes which particularly infect older…
AstraZeneca’s Tagrisso with chemo approved in China as 1st-line treatment
Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy reduced the risk of disease progression or death by…
Neurolief announces results from clinical trial of brain neuromodulation system
Neurolief previously received Breakthrough Device designation from the FDA for its technology targeting Major Depression
Sun Pharma’s Utreglutide shows weight loss, gluco-metabolic and lipid-lowering efficacy
GL0034 (Utreglutide) administered once weekly confirmed clinically meaningful weight loss and improved glucometabolic parameters…
EMA approves Biocon’s new mAbs facility in India
EMA also renews GMP certifications for Biocon’s India and Malaysia sites
FDA expands approval of gene therapy for patients with Duchenne Muscular Dystrophy
Elevidys now approved for both ambulatory and non-ambulatory patients aged four and older
Alembic Pharma announces U.S. FDA approval for Dabigatran Etexilate Capsules, 75 mg and 150 mg and…
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 75 mg, 110 mg, and…