Biotechnology | FDA | Therapeutics | Vaccine
U.S. FDA approved first Respiratory Syncytial Virus (RSV) vaccine
On May 3, 2023, the U.S. FDA approved GlaxoSmithKline’s Arexvy as the first respiratory syncytial virus (RSV) vaccine…
U.S. FDA announced additional steps to advance decentralized clinical trials
On May 2, 2023, the U.S. FDA announced that it was taking additional steps to support the use…
Biotechnology | FDA | Therapeutics | Vaccine
U.S. FDA approved PREVNAR 20, Pfizer’s 20-valent pneumococcal conjugate vaccine for infants and children
On Apr. 27, 2023, Pfizer announced that experimental respiratory syncytial virus (RSV) vaccine was 82% effective in preventing…
Vertex announced U.S. FDA approval for TRIKAFTAﾮ in children with cystic fibrosis ages 2 through 5 with certain mutations
On Apr. 26, 2023, Vertex announced the Food and Drug Administration (FDA) had approved the expanded use of…
U.S. FDA approved treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
On Apr. 25, 2023, the U.S. FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS)…
U.S. FDA issued Emergency Use Authorization for new COVID-19 Over-the-Counter at-home antigen test
On Apr. 24, 2023, the U.S. Food and Drug Administration (FDA) authorized Status COVID-19 Antigen Rapid Test for…
U.S. FDA approves cell therapy for patients with blood cancers to reduce risk of infection after stem cell transplantation
On Apr. 17, 2023, the U.S. FDA approved Gamida Cell’s Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord…
U.S. FDA Approved First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for the Treatment of Cervical Dystonia
On Apr. 14, 2023, Revance Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved the…
U.S. FDA issued EUA for new COVID-19 over-the-counter at-home antigen test
On Apr. 14, 2023, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the…
U.S. FDA approved first Over-the-Counter Naloxone nasal spray
On Mar. 29, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Narcan, 4 milligram naloxone…
Pfizer’s ZAVZPRET (zavegepant) Migraine Nasal Spray received FDA approval
On Mar. 10, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ZAVZPRET (zavegepant),…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics | Women's Health
FDA updated mammography regulations to require reporting of breast density information and facility oversight
On Mar. 9, 2023, the U.S. Food and Drug Administration (FDA) announced that it had published updates to…
Amphastar Pharmaceuticals received FDA approval for Naloxone hydrochloride nasal spray
On Mar. 8, 2023, Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had granted approval…
Biotechnology | COVID-19 | FDA
QuidelOrtho received de novo FDA authorization for Sofia 2 SARS Antigen+ FIA
On Mar. 8, 2023, QuidelOrtho announced that it had been granted a De Novo request from the U.S….
Biotechnology | FDA | Measles | Vaccine
U.S. FDA approved intramuscular administration for Merck’s MMRV Vaccines: M-M-RII, VARIVAX, and ProQuad
On Mar. 6, 2023, Merck announced that the U.S. Food and Drug Administration had approved the addition of…
FDA grants Lenireﾮ Tinnitus treatment device de novo approval
On Mar. 6, 2023, Neuromod Devices announced that the US Food and Drug Administration (FDA) had granted De…
Pfizer and BioNTech submitted for U.S. EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 booster in children under 5 years
On Mar. 1, 2023, BioNTech and Pfizer announced that they had submitted an application to the U.S. Food…
U.S. Government and Novavax extend partnership for 1.5 million additional doses of Novavax’ COVID-19 vaccine
On Feb. 13, 2023, Novavax announced a modification to its existing agreement with the U.S. Department of Health…
FDA authorized first Mpox point-of-care test
On Feb. 10, 2023, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for…
Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | Influenza | Vaccine
BD received FDA EUA for COVID-19, influenza A/B, RSV combination test
On Feb. 8, 2023, BD announced that it had received Emergency Use Authorization from the U.S. Food and…
Biotechnology | Diagnostics | Disease | FDA | Neurology | Therapeutics
FDA granted accelerated approval for Alzheimer’s disease treatment
On Jan. 6, 2023, the U.S. Food and Drug Administration (FDA) approved Leqembi (lecanemab-irmb) via the Accelerated Approval…
Biotechnology | FDA | Oncology | Therapeutics
The FDA approves Genentech’s updated drug labeling for Xeloda (capecitabine) under Project Renewal Pilot Program
On Dec. 24, 2022, the U.S. Food and Drug Administration (FDA) approved updated labeling for Genentech’s capecitabine tablets…
FDA approved Roche’s Actemra for treatment of COVID-19 in hospitalised adults
On Dec. 21, 2022, Roche announced that the U.S. Food and Drug Administration (FDA) had approved Actemraﾮ (tocilizumab)…
Biotechnology | COVID-19 | FDA | Influenza | Vaccine
Pfizer and BioNTech received U.S. FDA Fast Track Designation for single-dose mRNA-based vaccine candidate against COVID-19 and influenza
On Dec. 9, 2022, Pfizer and BioNTech announced the companies had received Fast Track Designation from the U.S….
Biotechnology | FDA | Oncology | Therapeutics
FDA granted approval to atezolizumab for alveolar soft part sarcoma
On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) approved Genentech’s atezolizumab (Tecentriq) for adult and…
Biotechnology | COVID-19 | FDA | Vaccine
Pfizer and BioNTech received U.S. FDA EUA for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children
On Dec. 8, 2022, Pfizer and BioNTech announced the U.S. Food and Drug Administration had granted Emergency Use…
FDA accepted for Priority Review the BLA for Pfizerﾒs Respiratory Syncytial Virus Vaccine candidate for prevention of RSV disease in older adults
On Dec. 7, 2022, Pfizer announced that the U.S. Food and Drug Administration (FDA) had accepted for priority…
Biotechnology | Disease | FDA | Therapeutics
FDA approved first drug that can delay onset of Type 1 Diabetes
On Nov. 17, 2022, the U.S. Food and Drug Administration (FDA) approved Tzield (teplizumab-mzwv) injection to delay the…
INOVIO Discontinued internal efforts to develop INO-4800 as COVID-19 heterologous booster vaccine Candidate
On Oct. 27, 2022, Inovio Pharma announced that it has discontinued its internally funded efforts to develop INO-4800…
FDA finalized historic rule enabling access to Over-the-Counter hearing aids for millions of Americans
On Oct. 19, 2022, the U.S. Food and Drug Administration final rule establishing Over-the-Counter Hearing Aids to improve…