Category: Biopharma

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...

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

July 8, 2024
Biopharma

USA FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test The U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress...

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

May 8, 2024
Biopharma

USA Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs The Food and Drug Administration (FDA or Agency) is announcing the availability...