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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)...
Merck's COVID-19 Pill Appears Effective, but May Pose Pregnancy Risks: FDA Drugs
November 30, 2021
Merck's experimental COVID-19 antiviral pill appears effective, but may pose risks for pregnant women, including birth defects and toxicity to developing fetuses, according to the U.S. Food and Drug Administration.
FDA gives expanded EUA for Pfizer-BioNTech Covid-19 vaccine booster dose Pharmaceutical-Business-Review
November 23, 2021
The expanded EUA allows the administration of booster dose to individuals of 18 years of age and older who have received primary dosages.
FDA grants expanded EUA to Pfizer-BioNTech’s Covid-19 booster shot Pharmaceutical-Technology
November 23, 2021
The US Food and Drug Administration (FDA) has granted expanded emergency use authorization (EUA) for the booster shot of Pfizer-BioNTech’s Covid-19 vaccine for use in people aged 18 years and above.
BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma AmericanPharmaceuticalReview
November 22, 2021
BioNTech SE announced that the FDA granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma.

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