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News about Global Pharma
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 | 165
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 | 200
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 | 161
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 | 145
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 | 130
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 | 180
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 | 176
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 | 349
Aurobindo Pharma Expands Business in Malaysia with New Subsidiary
Aurobindo Pharma has announced the incorporation of a new wholly owned subsidiary, Aurobindo Pharma (Malaysia) SDN. BHD., through its subsidiary Helix Healthcare B.V.
Global Pharma | 18/09/2025 | By Dineshwori | 514
Roche to Acquire 89bio in Deal Worth Up to USD 3.5 Billion
Roche has entered into a merger agreement to acquire 89bio, a San Francisco-based clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardiometabolic diseases.
Global Pharma | 18/09/2025 | By Dineshwori | 214
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