Torrent Pharmaceutical gets CDSCO Panel nod to study Gabapentin plus Duloxetine FDC Susmita Roy12 Nov 2024 5:15 PM ISTNew Delhi: Torrent Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Alembic Pharma bags USFDA nod for Ivabradine Tablets Ruchika Sharma12 Nov 2024 4:05 PM ISTVadodara: Alembic Pharmaceuticals Limited has announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for...
USFDA grants Breakthrough Therapy Designation to Nipocalimab for treatment of adults with moderate-to-severe Sjögren's disease: JnJ Ruchika Sharma12 Nov 2024 1:00 PM ISTSpring House: Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted nipocalimab Breakthrough Therapy...
USFDA removes clinical hold on Novavax COVID Influenza combination, stand alone Influenza Phase 3 trial Ruchika Sharma12 Nov 2024 11:00 AM ISTGaithersburg: Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, has announced that the U.S. Food and...
Patients be informed of risks in self-administration: CDSCO Panel tells Takeda Biopharm on Agalsidase Alfa Susmita Roy11 Nov 2024 6:00 PM ISTNew Delhi: In line with the proposal presented by Takeda Biopharmaceuticals for an update in the package insert regarding home infusion for Agalsidase...
Moderna bags Health Canada nod for RSV vaccine for adults aged 60 years and older Ruchika Sharma11 Nov 2024 4:43 PM ISTCambridge: Moderna, Inc. has announced Health Canada has approved mRESVIA (Respiratory Syncytial Virus mRNA vaccine) for active immunization for...
GSK RSV vaccine approved in Canada for adults aged 50-59 at increased risk Ruchika Sharma11 Nov 2024 1:00 PM ISTMississauga: GSK's AREXVY (respiratory syncytial virus vaccine - recombinant, AS01E adjuvanted) has been approved in Canada for the prevention of...
Alembic Pharma bags USFDA nod for hypertension drug Diltiazem Hydrochloride ER Ruchika Sharma11 Nov 2024 12:05 PM ISTVadodara: Alembic Pharmaceuticals Limited has announced that it has received Final Approval from the US Food & Drug Administration (USFDA)...
USFDA classifies Biocon Biologics Biocon Park Site in Bengaluru as VAI Ruchika Sharma11 Nov 2024 11:33 AM ISTBengaluru: Biocon has announced that the U.S. Food and Drug Administration (USFDA) has classified Biocon Biologics' facilities at Biocon Park,...
Intas Pharmaceuticals Gets CDSCO Panel Nod to Study R-hFSH Solution for Injection Dr. Divya Colin10 Nov 2024 6:00 PM ISTNew Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit safety data of Indian patients: CDSCO Panel Tells Sanofi Healthcare on Olipudase Alfa Dr. Divya Colin10 Nov 2024 5:15 PM ISTNew Delhi: Responding to the proposal presented by Sanofi Healthcare for updating the prescribing information of Olipudasealfa Powder for concentrate...
JnJ seeks approval from USFDA, EMA for DARZALEX FASPRO as subcutaneous monotherapy for high-risk smoldering multiple myeloma Ruchika Sharma10 Nov 2024 4:15 PM ISTRaritan: Johnson & Johnson has announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and...
