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Aprea Therapeutics Announces a Partial Clinical Hold on Myeloid Malignancy Programs firstwordpharma
August 06, 2021
Aprea Therapeutics, Inc. today announced that the FDA has placed a partial clinical hold on its clinical trials of eprenetapopt in combination with azacitidine in its myeloid malignancy programs.
Time to Rethink Suicide Warnings on Labels for Anti-Seizure Meds? drugs
August 05, 2021
Since 2008, anti-seizure drugs have carried a warning that they may increase users' suicide risk. But a new analysis finds no evidence of such a risk with newer medications.
Full Approval of Pfizer COVID-19 Vaccine Could Come in September drugs
August 05, 2021
The U.S. Food and Drug Administration is speeding up its timetable for full approval of the Pfizer coronavirus vaccine, hoping to complete the process by early September.
Complete Response Letter Received from FDA for Treosulfan drugs
August 05, 2021
Medexus Pharmaceuticals Inc. (“Medexus” or the “Company”) (TSX: MDP) (OTCQX: MEDXF) and medac GmbH (“medac”) announced today that medac, Medexus’ licensor for treosulfan, has received a Complete Response Letter (CRL) from FDA.
FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 fda.gov
August 05, 2021
The U.S. Food and Drug Administration today revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19.
USA Medical LLC Announces Free 48-hour Covid-19 Testing Kits prnewswire
August 05, 2021
Today, USA Medical LLC, a company focused on developing safe, accurate, and fast COVID-19 test kits, announced immediate availability of free test kits for all organizations.
US FDA grants priority review to Roche’s Tecentriq as adjuvant treatment for non-small cell lung cancer expresspharma
August 04, 2021
Tecentriq is the first and only cancer immunotherapy to demonstrate positive phase-III results in the adjuvant lung cancer setting.
Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis drugs
August 04, 2021
Ardelyx today announced that it has received a Complete Response Letter (CRL) from the FDA regarding the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis.
FDA approve emergency use of REGEN-COVTM for COVID-19 prevention europeanpharmaceuticalreview
August 03, 2021
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
AZ’s Saphnelo scores US approval for systemic lupus erythematosus pharmatimes
August 03, 2021
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Saphnelo (anifrolumab) for the treatment of moderate to severe systemic lupus erythematosus (SLE).

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