Drug Approval | 06 October 2021
EMA authorises booster dose of Moderna’s Spikevax
A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects
A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects
According to IQVIA, US sales of Everolimus (Afinitor) tablets were approximately US $ 675 million in the 12 months ending July 2021
Lilly will continue to maintain its existing operating model for the remaining portfolio of products
According to industry sales data, the 10mg strength of Afinitor generated annual sales of US $ 392 million during the twelve months ending July 2021
Ryaltris is a fixed dose combination nasal spray that combines an antihistamine (Olopatadine) with a steroid (Mometasone Furoate) for treatment of allergic rhinitis
Droxidopa capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA
India’s first gender-neutral HPV vaccine to help reduce HPV -related disease burden in Indian girls, women and boys
Prostate cancer is the second-most common cancer in men and despite an increase in the number of available treatments for men with mCRPC, five-year survival remains low
It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan
Chericof 12, the first prescription cough syrup in India which gives relief for up to 12 hours, is manufactured using Polistirex technology for sustained release of the drug
The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients
It paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses
Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
Clindamycin Phosphate Foam, 1% is the generic version of Evoclin Foam, 1%
Cephalosporin is a bactericidal, broad-spectrum, and P-lactam antibiotic originally derived from the fungus Acremonium, which is used to treat bacterial infections such as pneumonia, skin infections, ear infection, strep throat, staph infections, tonsillitis, bronchitis among others
With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
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