Category: Biopharma

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...

FDA Approval, Health Innovation, Medical Product Safety, Pharmaceutical Industry News, USFDA Approvals, Women Health

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...

Biotech Updates, Clinical Trials, Drug Safety, EMA, FDA, Global Health, Healthcare Regulations, Medical Devices, Pharma News, Regulatory News

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

June 19, 2024
Biopharma

USA EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology In response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable,...

Bio Pharma, Bio Tech, Biotech News, Biotechnology, Drug Approval, EMA, FDA, Global Health, Health News, Healthcare, Healthcare Innovation, Medical Updates, Pharma Industry, Pharma News, Pharma Regulations, Pharma Trends, Pharma2024, Pharmaceuticals, Regulatory Updates

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...

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

April 8, 2024
Biopharma

USA Three FDA Final Guidance’s on Electronic Submission of Safety Reports Three FDA final guidance’s address electronic submissions for reporting adverse reactions — one for investigational...

BioPharma Industry, Global Regulations, Industry News, Pharma Insights, Regulatory Updates