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Home / FDA - Page 6

FDA

Vertex and CRISPR Therapeutics announced U.S. FDA approval of CASGEVY for treatment of sickle Cell disease
Biotechnology | CRISPR | FDA | Genomics | Therapeutics

Vertex and CRISPR Therapeutics announced U.S. FDA approval of CASGEVY for treatment of sickle Cell disease

On Dec. 8, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that the U.S. Food and Drug Administration (FDA)…

Read More Vertex and CRISPR Therapeutics announced U.S. FDA approval of CASGEVY for treatment of sickle Cell diseaseContinue

bluebird bio announced commercial launch of LYFGENIA’ gene therapy for patients ages 12 and older with sickle cell disease
Biotechnology | FDA | Therapeutics

bluebird bio announced commercial launch of LYFGENIA’ gene therapy for patients ages 12 and older with sickle cell disease

On Dec. 8, 2023, bluebird bio announced the U.S. commercial launch of its LYFGENIA’ (lovotibeglogene autotemcel, also known…

Read More bluebird bio announced commercial launch of LYFGENIA’ gene therapy for patients ages 12 and older with sickle cell diseaseContinue

Novartis received FDA approval for Fabhaltaᆴ (iptacopan) as the first oral monotherapy for adults with PNH
FDA | Life Science History

Novartis received FDA approval for Fabhaltaᆴ (iptacopan) as the first oral monotherapy for adults with PNH

On Dec. 5, 2023, Novartis announced that the U.S. Food and Drug Administration (FDA) had approved Fabhaltaᆴ (iptacopan)…

Read More Novartis received FDA approval for Fabhaltaᆴ (iptacopan) as the first oral monotherapy for adults with PNHContinue

Emergent received $75 million contract option from BARDA to procure doses of CYFENDUS (Anthrax Vaccine)
Biotechnology | FDA | Infectious Disease | Vaccine

Emergent received $75 million contract option from BARDA to procure doses of CYFENDUS (Anthrax Vaccine)

On Nov. 28, 2023, Emergent BioSolutions announced that the Biomedical Advanced Research and Development Authority (BARDA) within the…

Read More Emergent received $75 million contract option from BARDA to procure doses of CYFENDUS (Anthrax Vaccine)Continue

FDA issued final guidance on developing drugs for COVID-19 treatment and preventionᅠ
Biotechnology | Clinical Research | COVID-19 | FDA | Infectious Disease | Medicine | NIH | Therapeutics | Vaccine

FDA issued final guidance on developing drugs for COVID-19 treatment and preventionᅠ

On Nov. 22, 2023, the U.S. Food and Drug Administration (FDA) issued the final guidance COVID-19: Developing Drugs…

Read More FDA issued final guidance on developing drugs for COVID-19 treatment and preventionᅠContinue

Masimo W1 Medical Watch received FDA 510(k) clearance for over-the-counter and prescription Use
Biology | Cardiology | FDA | Medical Device

Masimo W1 Medical Watch received FDA 510(k) clearance for over-the-counter and prescription Use

On Nov. 17, 2023, Masimo announced that the Masimo W1™ medical watch has received FDA 510(k) clearance for over-the-counter…

Read More Masimo W1 Medical Watch received FDA 510(k) clearance for over-the-counter and prescription UseContinue

FDA granted Marketing Authorization of first test for chlamydia and gonorrhea with at-home sample collection
FDA | HIV | Life Science History

FDA granted Marketing Authorization of first test for chlamydia and gonorrhea with at-home sample collection

On Nov. 15, 2023, the U.S. Food and Drug Administration granted marketing authorization to LetsGetChecked for the Simple…

Read More FDA granted Marketing Authorization of first test for chlamydia and gonorrhea with at-home sample collectionContinue

FDA cleared first COVID-19 home antigen test
Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | NIH

FDA cleared first COVID-19 home antigen test

On Nov. 9, 2023, the U.S. Food and Drug Administration (FDA) cleared for marketing the first over-the-counter (OTC)…

Read More FDA cleared first COVID-19 home antigen testContinue

FDA approved new medication for chronic weight management
Biotechnology | FDA | Therapeutics

FDA approved new medication for chronic weight management

On Nov. 8, 2023, the U.S. Food and Drug Administration approved Eli Lilly’s Zepbound (tirzepatide) injection for chronic…

Read More FDA approved new medication for chronic weight managementContinue

Abbott received FDA approval for HPV test to run on Alinity m family of diagnostic assays
FDA | Life Science History

Abbott received FDA approval for HPV test to run on Alinity m family of diagnostic assays

On Nov. 2, 2023, Abbott announced that it had received U.S. Food and Drug Administration (FDA) approval for…

Read More Abbott received FDA approval for HPV test to run on Alinity m family of diagnostic assaysContinue

FDA approved interchangeable biosimilar for multiple inflammatory diseases
Biotechnology | Disease | FDA | Therapeutics

FDA approved interchangeable biosimilar for multiple inflammatory diseases

On Oct. 31, 2023, the U.S. Food and Drug Administration (FDA) announced it had approved Amgen’s Wezlana (ustekinumab-auub)…

Read More FDA approved interchangeable biosimilar for multiple inflammatory diseasesContinue

FDA approved Novartis Cosentyx as the first new biologic treatment for hidradenitis suppurativa patients in a decade
FDA | Life Science History

FDA approved Novartis Cosentyx as the first new biologic treatment for hidradenitis suppurativa patients in a decade

On Oct. 31, 2023, Novartis announced that the US Food and Drug Administration (FDA) had approved Cosentyxᆴ (secukinumab)…

Read More FDA approved Novartis Cosentyx as the first new biologic treatment for hidradenitis suppurativa patients in a decadeContinue

FDA approved new therapy for rare form of blood cancers called myelodysplastic syndromes
FDA | Life Science History

FDA approved new therapy for rare form of blood cancers called myelodysplastic syndromes

On Oct. 24, 2023, the U.S. Food and Drug Administration approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) for the treatment…

Read More FDA approved new therapy for rare form of blood cancers called myelodysplastic syndromesContinue

FDA approved PENBRAYA,the first and only vaccine for prevention of most common serogroups causing meningococcal
Biotechnology | FDA | Infectious Disease | Neurology | Vaccine

FDA approved PENBRAYA,the first and only vaccine for prevention of most common serogroups causing meningococcal

On Oct. 20, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved PENBRAYA (meningococcal…

Read More FDA approved PENBRAYA,the first and only vaccine for prevention of most common serogroups causing meningococcalContinue

FDA authorized updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variant
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

FDA authorized updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variant

On Oct. 3, 2023, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of…

Read More FDA authorized updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variantContinue

Novavax 2023-2024 COVID-19 Vaccine  Authorized and Recommended for Use in the U.S.
Biotechnology | CDC | COVID-19 | FDA | Infectious Disease | Vaccine

Novavax 2023-2024 COVID-19 Vaccine Authorized and Recommended for Use in the U.S.

On Oct. 3, 2023, Novavax announced that it’s COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) had received Emergency Use…

Read More Novavax 2023-2024 COVID-19 Vaccine Authorized and Recommended for Use in the U.S.Continue

FDA launched pilot program to help further accelerate development of rare disease therapies
FDA | Life Science History

FDA launched pilot program to help further accelerate development of rare disease therapies

On Sept. 29, 2023, the U.S. Food and Drug Administration announced it was taking steps to help further…

Read More FDA launched pilot program to help further accelerate development of rare disease therapiesContinue

FDA granted first marketing authorization for DNA test to assess predisposition for dozens of cancer types
Biotechnology | Diagnostics | FDA

FDA granted first marketing authorization for DNA test to assess predisposition for dozens of cancer types

On Sept. 29, 2023, the U.S. Food and Drug Administration (FDA) granted Invitae de novo marketing authorization for…

Read More FDA granted first marketing authorization for DNA test to assess predisposition for dozens of cancer typesContinue

Amicus Therapeutics announced FDA approval and launch of treatment for Pompe disease
FDA | Life Science History

Amicus Therapeutics announced FDA approval and launch of treatment for Pompe disease

On Sept. 28, 2023, Amicus Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved Pombilitiル…

Read More Amicus Therapeutics announced FDA approval and launch of treatment for Pompe diseaseContinue

APHIS issued regulatory status review response for Ohalo Genetics potato
Agriculture | Biotechnology | FDA | USDA

APHIS issued regulatory status review response for Ohalo Genetics potato

On Sept. 26, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced…

Read More APHIS issued regulatory status review response for Ohalo Genetics potatoContinue

Moderna received U.S. FDA approval for updated COVID-19 vaccine
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Moderna received U.S. FDA approval for updated COVID-19 vaccine

On Sept. 11, 2023, Moderna announced the U.S. Food and Drug Administration (FDA) had approved the supplemental Biologics…

Read More Moderna received U.S. FDA approval for updated COVID-19 vaccineContinue

Pfizer and BioNTech received U.S. FDA approval for 2023-2024 COVID-19 vaccine
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

Pfizer and BioNTech received U.S. FDA approval for 2023-2024 COVID-19 vaccine

On Sept. 11, 2023, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) approved the…

Read More Pfizer and BioNTech received U.S. FDA approval for 2023-2024 COVID-19 vaccineContinue

Moderna clinical trial data confirmed updated Covid-19 vaccine generated strong immune response against BA.2.86 variant
Biotechnology | COVID-19 | FDA | Vaccine

Moderna clinical trial data confirmed updated Covid-19 vaccine generated strong immune response against BA.2.86 variant

On Sept. 6, 2023, Moderna announced that clinical trial data from its research assay confirmed its updated COVID-19…

Read More Moderna clinical trial data confirmed updated Covid-19 vaccine generated strong immune response against BA.2.86 variantContinue

FDA Cleared 23andMe improved BRCA report for communities underrepresented in genetic testing
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics | Women's Health

FDA Cleared 23andMe improved BRCA report for communities underrepresented in genetic testing

On Aug. 31, 2023, the U.S. Food and Drug Administration (FDA) cleared for marketing the updated 23andMe Personal…

Read More FDA Cleared 23andMe improved BRCA report for communities underrepresented in genetic testingContinue

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union
COVID-19 | FDA | Infectious Disease | Vaccine

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union

On Aug. 30, 2023, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…

Read More Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European UnionContinue

Aspirin can help prevent a second heart attack, but most don’t take it
Biotechnology | FDA | Pharmaceutical | Therapeutics

Aspirin can help prevent a second heart attack, but most don’t take it

On Aug. 22, 2023, a study led by researchers at Washington University School of Medicine in St. Louis…

Read More Aspirin can help prevent a second heart attack, but most don’t take itContinue

U.S. FDA approved ABRYSVO, Pfizer’s vaccine for prevention of RSV in infants through active immunization of pregnant Individuals
Biotechnology | FDA | Pharmaceutical | Vaccine

U.S. FDA approved ABRYSVO, Pfizer’s vaccine for prevention of RSV in infants through active immunization of pregnant Individuals

On Aug. 21, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO (Respiratory…

Read More U.S. FDA approved ABRYSVO, Pfizer’s vaccine for prevention of RSV in infants through active immunization of pregnant IndividualsContinue

U.S. FDA approved ZURZUVAE (zuranolone), the First and only oral treatment for Women with postpartum depression
Biotechnology | Diagnostics | FDA | Neurology | Women's Health

U.S. FDA approved ZURZUVAE (zuranolone), the First and only oral treatment for Women with postpartum depression

On Aug. 4, 2023, Biogen and Sage Therapeutics announced that the U.S. Food and Drug Administration (FDA) had…

Read More U.S. FDA approved ZURZUVAE (zuranolone), the First and only oral treatment for Women with postpartum depressionContinue

U.S. FDA approved Merck’s ERVEBO (Ebola Zaire Vaccine, Live) for use in children 12 months of age and older
Biotechnology | FDA | Infectious Disease | Vaccine

U.S. FDA approved Merck’s ERVEBO (Ebola Zaire Vaccine, Live) for use in children 12 months of age and older

On Aug. 3, 2023, Merck announced that the U.S. Food and Drug Administration (FDA) had approved an expanded…

Read More U.S. FDA approved Merck’s ERVEBO (Ebola Zaire Vaccine, Live) for use in children 12 months of age and olderContinue

Emergent BioSolutions awarded 10-Year BARDA contract valued at  $704 million for Ebanga treatment for Ebola
Biotechnology | FDA | Infectious Disease | Therapeutics | Vaccine

Emergent BioSolutions awarded 10-Year BARDA contract valued at $704 million for Ebanga treatment for Ebola

On Jul. 31, 2023, Emergent BioSolutions announced that it was awarded a 10-year contract by the Biomedical Advanced…

Read More Emergent BioSolutions awarded 10-Year BARDA contract valued at $704 million for Ebanga treatment for EbolaContinue

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