Lupin gains USFDA nod for Raltegravir Tablets USP, 600 mg
Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity
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Drug approvals
AstraZeneca’s Trastuzumab deruxtecan therapy receives CDSCO nod to manage HER2- low & ultra-low…
The medicine is now indicated as a monotherapy for the treatment of adult patients with unresectable or metastatic breast cancer
FDA approves trial to advance treatment for Hereditary Spastic Paraplegia (HSP)
The trial will be conducted in the United States at Boston Children’s Hospital and will assess the safety, tolerability, and…
Strides Pharma receives USFDA approval for Celecoxib Capsules in multiple strengths
Approval from USFDA allows Strides Pharma to market Celecoxib Capsules 100 mg, 200 mg, and 400 mg in the United States
Alembic Pharmaceuticals receives US FDA EIR for Panelav oncology facility
US FDA inspection for injectable and oral solid formulation unit conducted in October 2024 has been successfully closed
ENTOD Pharmaceuticals receives CDSCO approval for paediatric myopia treatment
The formulation, approved following Phase 3 trials in India, becomes the first globally authorised treatment strength for slowing…
Lupin receives US FDA approval for generic Tolvaptan Tablets
Company secures 180-day marketing exclusivity as first-to-file applicant for bioequivalent to Jynarque
Sanofi-Regeneron’s Dupixent gets FDA’s nod for skin condition
FDA clears Dupixent for chronic spontaneous urticaria in patients aged 12 and above, expanding its use in immune-related skin…
Cipla receives US FDA approval for generic version of Abraxane
Cipla secures final USFDA approval for Protein-bound Paclitaxel 100 mg/vial; launch planned in H1 FY26 in the US market
Biocon Biologics secures US FDA approval for Biosimilar Bevacizumab, JOBEVNE
The approval marks Biocon Biologics’ seventh biosimilar clearance in the US, expanding its oncology portfolio in one of the…
Alembic Pharmaceuticals secures US FDA approval for Pantoprazole Sodium Injection
Regulatory clearance enables Alembic to launch generic equivalent of Protonix I.V. in the US market
SPARC announces submission of IND application for SBO-154 to USFDA
SBO-154 set to enter global Phase 1 clinical trial for treatment of advanced solid tumours
FDA drug approvals drop 15.44%, but smaller pharma leads innovation: GlobalData
GlobalData’s bio/pharmaceutical outsourcing report highlights the reliance of smaller pharma companies on CDMOs for production,…
Lilly launches Mounjaro (tirzepatide), offers new treatment option for obesity and type 2 diabetes
Phase 3 SURPASS programme demonstrated that Mounjaro, whether used alone or with other diabetes medications, reduced A1C by up to…
Lupin gains tentative USFDA approval for Amifampridine Tablets
Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse Tablets, 10 mg of Catalyst Pharmaceuticals
Zydus receives final USFDA approval for Eluxadoline Tablets, 75 mg and 100 mg
Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea…
Zydus receives final USFDA approval for Ketoconazole Shampoo, 2%
Ketoconazole shampoo is an antifungal medication used to treat dandruff, fungal infections, and other skin conditions
AstraZeneca gains CDSCO approval to import SZC for treating Hyperkalaemia in adult patients
This treatment can enhance hyperkalaemia management in adults, a condition characterised by elevated potassium levels that often…
Lerodalcibep can be a treatment option for patients requiring additional LDL-C reduction: GlobalData
Lerodalcibep is a novel therapy designed to lower low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic…
Glenmark USA acquires and launches Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose…
Glenmark acquired the ANDA for Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials from Aspen Pharma USA