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Results For "regulatory"

1426 News Found

India’s Drugs Controller General green lights trial of TRIA heart valve
News | May 04, 2022

India’s Drugs Controller General green lights trial of TRIA heart valve

The procedures have been performed by Dr. Kaushal Pandey at P.D. Hinduja Hospital in Mumbai, India


Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone
Biotech | May 02, 2022

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone

The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023


Global Cord Blood Corp acquires Cellenkos to advance cell therapy market
Biotech | May 01, 2022

Global Cord Blood Corp acquires Cellenkos to advance cell therapy market

CLNK is a biotechnology research and development company that utilizes umbilical cord blood as the raw material to develop innovative, allogeneic, off-the-shelf, cell based therapeutic products


Ultomiris approved in the US for adults with generalised myasthenia gravis
Drug Approval | April 29, 2022

Ultomiris approved in the US for adults with generalised myasthenia gravis

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks


Moderna files for authorization of its Covid-19 vaccine in young children six months to six years
Biotech | April 29, 2022

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years

Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children


Sanofi continues to deliver strong business
News | April 28, 2022

Sanofi continues to deliver strong business

Business EPS of €1.94, up 20.5% on a reported basis and 16.1% at CER, also benefitting from an improved effective tax rate


USFDA grants Breakthrough Device designation to Nocria’s Migraine treatment
Biotech | April 28, 2022

USFDA grants Breakthrough Device designation to Nocria’s Migraine treatment

Nocria’s hand-held device uses gentle, controlled puffs of air in the ears for treating migraine attacks


Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance
People | April 27, 2022

Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance

Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)


Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer
Biotech | April 27, 2022

Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers


Tislelizumab plus chemo show promising results for esophageal cancer in Phase III study
Biotech | April 27, 2022

Tislelizumab plus chemo show promising results for esophageal cancer in Phase III study

Results support the development of tislelizumab in potentially synergistic combinations across Novartis advanced therapeutic platforms for the treatment of an array of solid tumours