Moderna, Immatics Ink Strategic Multi-Platform Collaboration To Develop Oncology Therapeutics

Moderna Shares Gain On FDA Approval For New COVID-19 Vaccine

Shares of Moderna, Inc. were gaining around 5 percent in the pre-market activity on the Nasdaq after its new Covid-19 vaccine, mNEXSPIKE, received approval from the U.S. Food and Drug Administration for limited use. mNEXSPIKE (mRNA-1283), a new vaccine to protect against COVID-19, is for people who have received a COVID-19 vaccine before. It can now be used in all adults 65 and older, as well as..

RTTNews | 94 dias atrás

FDA Approves Updated Pfizer, Moderna Covid Vaccines Against Current Variants

The U.S. Food and Drug Administration approved and granted emergency use authorization or EUA for updated Covid vaccines from Pfizer Inc. and ModernaTX Inc. for use against currently circulating variants. The approval for the updated mRNA COVID-19 vaccines (2024-2025 formula) comes as the Covid cases are surging in the United States.

RTTNews | 377 dias atrás

Moderna Says CHMP Recommends Marketing Authorization For MRESVIA RSV Vaccine In EU

Moderna, Inc. (MRNA) announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization in the European Union for mRESVIA (mRNA-1345) to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

RTTNews | 433 dias atrás

Moderna Reports Positive Phase 3 Data For Flu And COVID Combination Vaccine

Moderna, Inc. (MRNA) announced Monday that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints. Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine.

RTTNews | 451 dias atrás

Moderna Stock Up 6% As Q4 Results Top Estimates

Biotechnology company Moderna reported a profit for the fourth quarter that plunged from last year, reflecting a sharp drop in COVID-19 vaccines sales. However, both earnings per share and revenues for the quarter topped analysts' expectations. The company also reaffirmed its 2024 product sales outlook.

RTTNews | 560 dias atrás

CDC Recommends Updated Pfizer, Moderna COVID-19 Vaccine

The Centers for Disease Control and Prevention or CDC has recommended everyone 6 months and older to get an updated COVID-19 vaccine ahead of the virus season this fall and winter. The agency expects the updated COVID-19 vaccines from Pfizer-BioNTech and Moderna, which was approved by the U.S. Food and Drug Administration earlier this week, to be available later this week.

RTTNews | 722 dias atrás

Moderna Says Clinical Trial Data Shows Updated COVID Vaccine Very Effective Against BA.2.86 Variant

Moderna, Inc. (MRNA) announced Wednesday that clinical trial data from its research assay confirm its updated COVID-19 vaccine generates an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86 (Pirola), a variant under monitoring.

RTTNews | 729 dias atrás

FDA Authorizes Changes To Simplify Use Of Moderna, Pfizer Bivalent COVID-19 Vaccines

The U.S. Food and Drug Administration said it has amended the emergency use authorizations or EUAs of COVID-19 bivalent mRNA vaccines of ModernaTX Inc. and Pfizer-BioNTech to simplify the vaccination schedule for most individuals. With the changes, the current bivalent vaccines, for original and omicron BA.4/BA.5 strains, can be used for all doses administered to individuals 6 months of age and...

RTTNews | 869 dias atrás

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