October 20, 2021 Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:…
MIAMI, Oct. 19, 2021 Intrivo announced today the launch of On/Go™, an at-home rapid COVID-19 antigen self-test that delivers results with 95% accuracy in just 10 minutes. On/Go, which has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), is an affordable and easy-to-use self-test with a…
PRINCETON, N.J., October 18, 2021 Oyster Point Pharma, Inc. (Nasdaq: OYST), announced that the U.S. Food and Drug Administration (FDA) has approved TYRVAYA™ (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray is the first and only nasal spray…
FOSTER CITY, Calif October 18, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) announced the U.S. Food and Drug Administration (FDA) approved a new low-dose tablet dosage form of Biktarvy® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who…
Ridgefield, Conn., October 15, 2021 Boehringer Ingelheim announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Cyltezo® (adalimumab-adbm) as the first Interchangeable biosimilar with Humira® (adalimumab). The FDA originally approved Cyltezo® in 2017 for the treatment of multiple chronic inflammatory diseases and this latest approval designates…
Basel, 15 October 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-approved…
Oct 14, 2021 Hyderabad-based Dr Reddy's Laboratories has become the first Indian pharmaceutical company to launch an anti-cancer drug Abiraterone Acetate in the Chinese market, India's ambassador to China Vikram Misri said in a tweet on October 13. The drug used in cancer treatment is a therapeutic equivalent generic version…
INDIANAPOLIS, Oct. 13, 2021 The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's (NYSE: LLY) Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early…
KENILWORTH, N.J. October 13, 2021 Eastern Daylight Time The FDA approved combining Merck & Co.'s anti-PD-1 therapy Keytruda (pembrolizumab) plus chemotherapy, with or without Roche's Avastin (bevacizumab), for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 with a combined positive score (CPS) ≥1. The approval is…
AHMEDABAD, India, Oct. 12, 2021 Intas Pharmaceuticals, has made a progressive breakthrough in the Antifungal Therapy domain with the launch of the world's first Super Bioavailable Itraconazole-SB 100mg by the Brand Name of Itaspor-SB Forte/Subawin. It has been recently approved by Indian Regulatory Authorities. Conventional Itraconazole mainstay drug to fight fungal infection…
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