Drug Approval | 21 December 2024
USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)
Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery
The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market
An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
Final decision from the European Commission is anticipated within the coming months
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
This product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients
For people with relapsed or refractory diffuse large B-cell lymphoma
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander
Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan
If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
The product will be manufactured at Lupin’s Somerset facility in the US
Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis
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