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Results For "grants"

158 News Found

FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections
Drug Approval | January 02, 2025

FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections

MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria


EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
Drug Approval | November 13, 2024

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections


FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777
Drug Approval | October 08, 2024

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy


Arkema grants technology license to Seqens to manufacture PEKK for sale in medical implantable applications
News | June 25, 2024

Arkema grants technology license to Seqens to manufacture PEKK for sale in medical implantable applications

PEKK is a high-performance polymer family used in aerospace and other demanding markets


FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma
Drug Approval | May 30, 2024

FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma

Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients


FDA grants full approval for TIVDAK to treat cervical cancer
Drug Approval | May 02, 2024

FDA grants full approval for TIVDAK to treat cervical cancer

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer


USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria
News | April 17, 2024

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections


USFDA grants ODD to Cevidoplenib for immune thrombocytopenia
News | March 23, 2024

USFDA grants ODD to Cevidoplenib for immune thrombocytopenia

Oscotec has successfully completed phase 2 study in patients with chronic ITP last year


USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children
Drug Approval | March 12, 2024

USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children

CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications


USFDA grants Orphan Drug Designation for iOnctura's first-in-class autotaxin cancer therapy
Biotech | March 12, 2024

USFDA grants Orphan Drug Designation for iOnctura's first-in-class autotaxin cancer therapy

It is the first autotaxin inhibitor to be investigated in cancer patients