US FDA grants breakthrough therapy designation to Roche’s anti-amyloid beta antibody gantenerumab
Gantenerumab is an investigational antibody in phase-III development for early Alzheimer's disease (AD)
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Drug approvals
Zydus Cadila gets USFDA approval for Vortioxetine Tablets
Vortioxetine is used to treat depression. It works by helping to restore the balance of a certain natural substance (serotonin) in…
FDA approves Cara’s drug for severe itching in kidney disease patients
The drug is designed to be administered three times a week after each dialysis
Zydus Cadila gets US FDA approval for Tofacitinib extended-release 22 mg tablet
Zydus was the first ANDA filer on Tofacitinib extended-release tablets 22 mg and
currently holds 180-day exclusivity on this…
US FDA approves Jardiance to treat adults living with heart failure with reduced ejection fraction
Heart failure accounts for more than one million hospitalisations a year in the US
Novartis secures approval in China for Cosentyx
This approval in China follows the recent approval of Cosentyx in the United States and Europe for the treatment of…
EMA validates Bristol Myers Squibb’s two Opdivo-based applications to treat cell carcinoma
The applications are based on positive results from the phase-III CheckMate-648 trial, in which both Opdivo-based combinations…
GSK receives US FDA approval for Jemperli to treat advanced solid tumours
GARNET study demonstrated an objective response rate of 41.6 per cent across dMMR solid tumours
Zydus Cadila receives final approval from US FDA for Mesalamine Extended-Release capsules
The capsules are indicated for the maintenance of remission of ulcerative colitis in adults
Lupin receives tentative US FDA approval for Brivaracetam tablets
The product will be manufactured at Lupin’s Nagpur facility in India
USFDA gives nod to Cipla’s generic product
According to IQVIA (IMS Health), Durezol had US sales of around $106 million for the 12-month period ending June 2021
US FDA approves Nexviazyme for late-onset Pompe disease
The approval is based on the positive phase-III data demonstrating improvements in key disease burden measures and establishing…
Zydus Cadila receives final approval from US FDA for Fulvestrant injection
The drug will be manufactured at the group’s formulation manufacturing facility at Zydus Biologics, Ahmedabad
Biocon Biologics and Viatris receive US FDA approval for maiden interchangeable biosimilar Semglee
Interchangeable designation allows substitution at the pharmacy counter for Lantus across the US to help increase access to…
US FDA approves Shingrix to prevent shingles in immuno-compromised adults
Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA…
Zydus Cadila receives tentative approval from USFDA for Ibrutinib
The drug will be manufactured at the group’s formulation manufacturing facility at the Special Economic Zone (SEZ), Ahmedabad
EMA grants Orphan Drug Designation to Saroglitazar Mg for treating patients with PBC
The Orphan drug status in Europe is given to medicines with the potential to be safe and effective treatments for rare,…
China approves Imfinzi to treat small cell lung cancer
Only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination with a…
Chugai Pharma obtains regulatory approval for anti-SARS-CoV-2 monoclonal antibody Ronapreve
The special approval for emergency under article 14-3 of the Pharmaceuticals and Medical Devices Act was applied to this approval
Merck gets US FDA nod of adult pneumococcal 15-valent conjugate vaccine
VAXNEUVANCE demonstrated non-inferior immune responses for the serotypes shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,…