... Feb 24
Forge Biologics receives FDA fast track, orphan drug, and rare pediatric disease designations for FBX-101 gene therapy for patients with krabbe disease ... Feb 17
Lupin & its AET Pharma US Inc. (part of Tiefenbacher Group) received an approval for its ANDA from the USFDA... Feb 17
The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA... Jan 18
Genmab announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (... Jan 16
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug, Truvada Tablets, 200 mg/300 mg, of Gilead Sciences... Jan 15
XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people ... Jan 15
Meloxicam Capsules indicated for the management of osteoarthritis pain... Dec 29
LORBRENA is a third-generation ALK inhibitor specifically developed to inhibit the most common tumour mutations that drive resistance to current medications and to address ... Dec 29
Annamycin is capable of reaching 6 to 34-fold higher levels of accumulation in the lungs than that of doxorubicin, the primary first-line chemotherapy ... Dec 29
Another USFDA approval for Lupin... Dec 18
CNS Pharma will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed ... Dec 18
The medication is used to treat overactive bladder and urinary conditions... Dec 18
The approval for MARGENZA was based on data from SOPHIA, a randomized Phase 3 clinical trial... Dec 17
Shorter infusion time will further improve the twice-yearly treatment experience for OCREVUS, the only B-cell therapy for relapsing and primary progressive MS with ... Dec 15
Entera Bio receives US FDA approval of IND application for EB613 – an oral human parathyroid hormone (1-34) for the treatment of osteoporosis ... Dec 11
Novo Nordisk is offering a new treatment option for adolescents with obesity and their families in the US... Dec 05
This test may help identify recovering patients who could potentially be serum and plasma donors for developing treatments for COVID-19... Dec 03
Alembic has a cumulative total of 137 ANDA approvals (118 final approvals and 19 tentative approvals) from USFDA... Dec 03
Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations... Dec 03
Penicillamine Tablets USP, 250 mg, are indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis... Dec 01
Polaryx Therapeutics has received from the US FDA both Rare Pediatric Disease and Orphan Drug designations for the treatment of GM2 gangliosidosis with PLX-300... Nov 25
ARCA believes that AB201 is the only anticoagulant class new chemical entity in development for COVID-19 that has a Fast Track designation... Nov 24
AskBio and Selecta expect to initiate a Phase 1 clinical trial of MMA-101 and ImmTOR for patients with MMA in the first half of ... Nov 21
Protagonist Therapeutics has previously received orphan drug designation for the treatment of polycythemia vera from US FDA... Oct 22
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Friday, April 11, 2025
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