You are here: Industry Insights > FDA

News List

FDA OKs Antibody Cocktail to Help Immune-Compromised Fend Off COVID Drugs
December 10, 2021
The U.S. Food and Drug Administration on Wednesday granted emergency approval of a new antibody cocktail to prevent COVID infection in people who have weakened immune systems or who can't tolerate COVID vaccines.
FDA Priority Review for supplemental Biologics License Application for Reblozyl® in Adults with Beta Thalassemia AmericanPharmaceuticalReview
December 06, 2021
Bristol Myers Squibb announced that the FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl® (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults...
FDA Priority Review for BLA for Merck’s VAXNEUVANCE for Use in Infants and Children AmericanPharmaceuticalReview
December 02, 2021
Merck announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal...
FDA Advisory Committee Votes for Oral Antiviral Molnupiravir to Treat COVID-19 in High Risk Adults AmericanPharmaceuticalReview
December 02, 2021
Merck and Ridgeback Biotherapeutics provided the following statement at the conclusion of the FDA Antimicrobial Drugs Advisory Committee (AMDAC) regarding the Emergency Use Authorization (EUA) application for molnupiravir (MK-4482, EIDD-2801)...
Avacta Announces FDA Approval of its Investigational New Drug Application for AVA6000 AmericanPharmaceuticalReview
December 02, 2021
Avacta Group plc, a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, announced that the FDA has approved its Investigational New Drug...
FDA Panel Mulls Merck's Molnupiravir COVID-19 Antiviral Pill Drugs
December 01, 2021
A U.S. Food and Drug Administration advisory panel is meeting Tuesday to weigh both the safety and power of Merck's new antiviral pill in preventing severe COVID-19.
FDA approves new imaging drug to identify ovarian cancer lesions EuropeanPharmaceuticalReview
December 01, 2021
The US Food and Drug Administration (FDA) has approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions.
Bristol Myers Squibb’s Applications for Deucravacitinib for the Treatment of Plaque Psoriasis Accepted by FDA and Validated by European Medicines Agency AmericanPharmaceuticalReview
December 01, 2021
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for ...
FDA Approves Takeda’s LIVTENCITY as the First and Only Treatment for Post-Transplant Cytomegalovirus AmericanPharmaceuticalReview
December 01, 2021
Takeda Pharmaceutical Company Limited announced that the FDA has approved LIVTENCITY (maribavir) for the treatment of adults and pediatric patients (12 years of age or older and weighing at least 35 kg) ...
FDA Approves Cytalux Drugs
November 30, 2021
On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent imaging agents to target and illuminate cancer during surgery, today announced that the U.S. Food and Drug Administration (FDA)...

Previous page 1 2 3 4 5 6 7 8 9 10 ... 365 366 Next page