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Susvimo (PDS with ranibizumab) is approved by FDA treatment for neovascular or “wet” age-related macular degeneration (nAMD)

2021-10-23 2,204 Times Ranibizumab

Basel, 22 October 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to…
Opdivo (nivolumab) + Chemotherapy is approved by the European Commission for Patients with HER2 Negative, Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma

2021-10-23 1,615 Times Nivolumab

PRINCETON, N.J. (10/21/2021) Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express…
$Brukinsa (zanubrutinib) is approved in the Russia to treat patients with relapsed or refractory mantle cell lymphoma (MCL)$

Brukinsa (zanubrutinib) is approved in the Russia to treat patients with relapsed or refractory mantle cell lymphoma (MCL)

2021-10-22 1,070 Times Zanubrutinib

CAMBRIDGE, Mass. & BEIJING & MOSCOW October 20, 2021 The Russia Ministry of Health has approved BeiGene’s Brukinsa (zanubrutinib) to treat patients with relapsed or refractory mantle cell lymphoma (MCL). Marketing approval for BRUKINSA for the treatment of MCL in Russia is based on results from two single-arm clinical trials.…
Digital Therapeutic Luminopia One is approved in the US for Improve Vision in Children with Amblyopia

2021-10-21 1,708 Times Amblyopia Digital Therapeutic

USA，CAMBRIDGE, Mass October 20, 2021 Luminopia, a digital therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted de novo premarket approval for Luminopia One as a prescription therapy to improve vision in children with amblyopia (lazy eye), the leading cause of vision loss in children.…
FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

2021-10-21 1,687 Times Public Health Covid-19

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:…
On/Go™(AI-powered mobile app) is authorized by FDA rapid COVID-19 self-test unique

2021-10-20 1,645 Times Public Health Covid-19

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…
TYRVAYA™(varenicline solution) Nasal Spray is approved in the US for the Treatment of the Signs and Symptoms of Dry Eye Disease

2021-10-19 1,628 Times Dry Eye Disease Varenicline

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…
Biktarvy（Low-Dose Tablet）is approved in the US for Treatment of HIV-1 in Children Weighing at Least 14 kg

2021-10-19 876 Times HIV Biktarvy

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…
U.S. FDA Approves Cyltezo® (adalimumab-adbm)as First Interchangeable Biosimilar with Humira

2021-10-18 1,618 Times Adalimumab

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…
Tecentriq（atezolizumab）is approved in the US as adjuvant treatment for certain people with early non-small cell lung cancer

2021-10-16 1,663 Times Atezolizumab

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…