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Copan Diagnostics Invests USD 7 Million to Expand US Manufacturing Footprint
Copan Diagnostics, part of the privately held Italy-based Copan Group, has announced more than USD 7 million in new US manufacturing investments across its facilities in California and Puerto Rico.
Global Pharma | 25/09/2025 | By Dineshwori | 376
US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer
The US FDA has granted Priority Review to Enhertu + Pertuzumab for HER2+ metastatic breast cancer, following DESTINY-Breast09 trial results showing a 44 percent reduction in risk of disease progression or death and over three years’ median Progression-Free Survival (PFS), positioning it as a potential new first-line standard of care.
Global Pharma | 25/09/2025 | By Dineshwori | 210
Alembic Wins USFDA Clearance for Paroxetine ER Tablets for Depression and Anxiety Disorders
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg.
Global Pharma | 25/09/2025 | By Dineshwori | 212
Lupin Receives Tentative Approval from US FDA for its HIV treatment tablets
Lupin has received tentative US FDA approval for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets to treat HIV, bioequivalent to Gilead’s Biktarvy, for adults and paediatric patients over 25 kg.
Global Pharma | 25/09/2025 | By Dineshwori | 243
US FDA Declines Approval for Biogen's Higher-Dose Spinraza in SMA
The decision was relayed via a ‘complete response letter’ to Biogen, which clarified there were no issues with the clinical data behind the new high-dose regimen. Biogen says it will resubmit the application promptly, drawing on information that is already at hand.
Global Pharma | 24/09/2025 | By Darshana | 193
Australia Approves Leqembi for Early Alzheimer's Disease Following TGA-Eisai Agreement
The Therapeutic Goods Administration (TGA) of Australia has approved lecanemab (Leqembi), developed collaboratively by BioArctic and Eisai, for the treatment of adult patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (early AD).
Global Pharma | 24/09/2025 | By Dineshwori | 207
Palatin Technologies, the US-based biopharmaceutical company focused on developing medicines that modulate the melanocortin receptor system, announced it has achieved a research milestone under its collaboration with Boehringer Ingelheim, triggering a 6.5 million payment to the company.
Global Pharma | 23/09/2025 | By Dineshwori | 170
Pfizer to Acquire Metsera, Expand Obesity and Cardiometabolic Drug Pipeline
Pfizer is set to acquire Metsera, a clinical-stage biopharmaceutical company focused on developing the next generation of medicines for obesity and cardiometabolic diseases.
Global Pharma | 23/09/2025 | By Dineshwori | 226
Alnylam Pharmaceuticals Joins Alliance for Genomic Discovery to Advance RNAi Therapeutics
Alnylam Pharmaceuticals has become the ninth member of the Alliance for Genomic Discovery (AGD), joining AbbVie, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, GSK, Merck, and Novo Nordisk.
Global Pharma | 19/09/2025 | By Dineshwori | 209
Laborate Pharmaceuticals Appoints IPS Veteran Sanjay Kundu as Independent Director
As Independent Director at Laborate Pharmaceuticals, Sanjay Kundu will provide independent oversight, strengthen corporate governance, and promote transparent decision-making.
Global Pharma | 18/09/2025 | By Dineshwori | 499
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