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ORPHAN DRUG DESIGNATION
Indian pharma leaving generics era behind, but the Street hasn't caught up yet: Nandan KulkarniIndian pharma is shifting from generics to innovation. This transformation, extending to 2035, is creating significant new opportunities. C...- Hantavirus scientists were close to vaccine but ran out of moneyScientists in Chile developed antibodies that successfully neutralised the deadly Andes hantavirus in lab and animal studies, raising hopes...
- Zydus’ Desidustat gets USFDA orphan drug status for sickle cell diseaseZydus Lifesciences announced a significant development today. The US Food and Drugs Administration has granted Orphan Drug Designation to D...
- Zydus gets USFDA's orphan drug designation for beta-thalassemia productZydus Lifesciences announced a significant development for beta-thalassemia patients. The US Food and Drug Administration has granted Orpha...
- Zydus receives USFDA Orphan Drug Designation for Usnoflast to treat ALSZydus Lifesciences announced that the USFDA granted Orphan Drug Designation to Usnoflast, a novel oral NLRP3 inhibitor, for treating amyotr...
- High costs of orphan drugs: Patients pay the price for policy hurdles in IndiaIndia manufactures APIs for over 400 FDA-approved orphan drugs, but patients face high costs due to Indian pharmaceutical companies' reluct...
- Glenmark forms alliance with Ichnos to develop anti-cancer drugsGlenmark Pharmaceuticals and Ichnos Sciences have formed an alliance called Ichnos Glenmark Innovation (IGI) to accelerate cancer drug disc...
- Sun Pharmaceutical launches phenobarbital sodium injection in US"The launch of SEZABY is an exciting addition to our growing portfolio of specialty branded products in the US," Sun Pharma CEO North Ameri...
- Sun Pharma gets USFDA nod for drug to treat neonatal seizures"With this approval, SEZABY becomes the first and only product specifically indicated in the US for the treatment of neonatal seizures in t...
- Lupin enters pact with Medis to distribute orphan drug in EuropeNDM disorders are a group of rare, inherited neuromuscular disorders which is characterized by the inability to relax muscles following vol...
- Zydus Cadila receives orphan drug status from USFDA for its novel malaria drugDrug maker Cadila Healthcare (Zydus Cadila), on Thursday said its antimalarial drug ZY19489 (MMV253), currently in development together wit...
- RGCB research proves anti-cancer capabilities of black nightshade leaves"The berry-bearing black nightshade shrub is proving to possess the potency to treat liver cancer, as the compound, Uttroside-B isolated fr...
- European Medicines Agency grants Orphan Drug Designation to Zydus Cadila's Saroglitazar MgOrphan Drug status in Europe is given to medicines with the potential to be safe and effective treatments for rare, life-threatening, or ch...
- Rhizen's cancer drug Umbralisib gets USFDA nod: Alembic PharmaAlembic Pharma on Tuesday said its associate company Rhizen Pharmaceuticals AG's product Umbralisib, which was licensed to TG Therapeutics,...
- USFDA grants orphan drug designation to Zydus Cadila's Saroglitazar MgZydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, includ...
- Rhizen receives USFDA orphan drug designation for cancer drugThe US Food and Drug Administration (USFDA) has granted orphan drug designation for Tenalisib (RP6530) for the treatment of patients with p...
- Lupin inks distribution pact with 3 firms to commercialise NaMuscla in EuropeExeltis Healthcare SL, Cresco Pharma BV and Macure Pharma ApS will commercialise NaMuscla for the symptomatic treatment of myotonia in adul...
- Rhizen receives USFDA orphan drug designation for cancer drugThe USFDA has granted orphan drug designation for Tenalisib (RP6530)... for the treatment of patients with peripheral T-cell lymphoma (PTCL...
- Aten Porus Lifesciences: Firm is developing drugs to fight a host of rare diseases globallyTo begin with, the duo decided to focus on Niemann-Pick Type C (NPC) disorder that’s also referred to as Childhood Alzheimer’s.
- Stempeutics' Stempeucel gets Orphan Drug status in EuropeAn orphan designation allows a company to benefit from incentives from the European Union to develop a medicine for a rare disease.
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