Category: Biopharma

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Jan 2025

February 5, 2025
Biopharma

USA FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain The U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class...

BioPharma, BioTech, Clinical Trials, Drug Approval, EMA, FDA, Healthcare Pharma Regulations, Pharma News, Regulatory Updates

2024 Recap: BioPharma key Regulation/Guidance in USA, EU, Asia and ROW

December 16, 2024
Biopharma

USA EUROPE ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BHUTAN BRAZIL CANADA CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA ...

Asia Pharma Regulations, Bio Pharma Regulations, EU Pharma Guidance, Global Regulatory Updates, Pharma Guidance 2024, Pharma Trends 2024, Regulatory Compliance.Global Pharma, ROW Compliance, USA Regulations 2024

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Oct 2024

November 6, 2024
Biopharma

USA FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer The Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet...

Approval Healthcare Updates, Biotech News, Cancer Treatment, Drug Approval, FDA, Medical Advancements, Medicines, Patient Care, Pharma News, Regulatory News

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Sept 2024

October 7, 2024
Biopharma

USA FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia The U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral...

Asia Regulations, Drug Approvals, EMA, Europe Pharma, FDA, Global Health, Safety Updates, USA Drug Updates

Pharma/Biotech – USA, UK, Asia and ROW Regulatory News – Aug 2024

September 5, 2024
Biopharma

USA FDA Approves First Nasal Spray for Treatment of Anaphylaxis The U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions...

COVID19 Vaccines, Drug Updates, FDA Approvals, Healthcare News, Medical News, Overdose Treatment, Pharma Updates, Regulatory News, Regulatory Updates

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – July 2024

August 8, 2024
Biopharma

USA The FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl...