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…
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Novartis received FDA approval for Fabhalta (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 Fabhalta (iptacopan)…
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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…
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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…
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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…
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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…
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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)…
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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…
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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…
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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 Cosentyx (secukinumab)…
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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)…
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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…
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FDA established new advisory committee on digital health technologies
On Oct. 11, 2023, the U.S. Food and Drug Administration (FDA) announced the creation of a new Digital…
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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…
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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…
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FDA launched pilot program to help further accelerate development of rare disease therapies
On Sept. 29, 2023, the U.S. Food and Drug Administration (FDSA) announced it was taking steps to help…
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Biotechnology | Diagnostics | FDA | Oncology
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…
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Amicus Therapeutics announced FDA approval and launch of treatment for Pompe disease
On Sept. 28, 2023, Amicus Therapeutics’ treatment for a rare muscle disorder called Pompe disease was approved by…
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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…
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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…
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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…
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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…
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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, 23andMe, a leading human genetics and biopharmaceutical company, today announced the Company has received…
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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)…
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U.S. FDA approved first biosimilar to treat Multiple Sclerosis
On Aug. 24, 2023, the U.S. Food and Drug Administration (FDA) approved Sandoz’s Tyruko (natalizumab-sztn), the first biosimilar…
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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…
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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…
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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…
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Biotechnology | FDA | Infectious Disease | Vaccine | WHO
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…
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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…
