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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.
FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism FDA
November 22, 2021
Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates）...
Zydus Cadila gets 180-day exclusivity for Nelarabine injection, announces final approval from US FDA ExpressPharma
November 19, 2021
Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market Nelarabine injection 250mg/50ml in the US. Zydus was granted a Competitive Generic Therapy (CGT) designation...
Pfizer seeks EUA for Covid-19 antiviral pill in US Pharmaceutical-Business-Review
November 18, 2021
Pfizer has submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of its investigational oral antiviral drug, Paxlovid (PF-07321332; ritonavir).
FDA approves Besremi to treat rare blood disease EuropeanPharmaceuticalReview
November 17, 2021
The FDA approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells.
Lunit Gets FDA Nod for AI-based Chest X-ray Triage Solution, Developed for Sorting of Emergency Cases prnasia
November 16, 2021
Lunit, a leading medical AI provider, today announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest x-ray triaging solution, 'Lunit INSIGHT CXR Triage'.
FDA Approves Treatment for Rare Blood Disease FDA
November 16, 2021
Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells.

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