AbbVie’s Vyalev receives US FDA approval to treat adults living …
3 days ago · AbbVie announced that the US Food and Drug Administration (FDA) has approved Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). "For too long, the Parkinson's community has had limited ...
Annovis Bio gets US FDA clearance to begin pivotal phase 3 …
4 days ago · Malvern headquartered Annovis Bio Inc, a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease and Parkinson’s disease, announced the successful outcome of the end-of-phase 2 meeting with the US Food and Drug ...
Pharma exports report 8% growth during first six months of …
1 day ago · Imports of medicinal and pharmaceutical products grew 5.44 per cent during the first six months of the fiscal year, at around $4.3 billion as compared to $4.08 billion in the same period last year. For the month of September, 2024, the growth in imports was around 4.5 per cent at $651.29 million as compared to $623.33 million a year ago.
Cullinan Therapeutics gets US FDA clearance to proceed phase 1 …
4 days ago · Cullinan Therapeutics, Inc., a biopharmaceutical company focused on developing modality-agnostic targeted therapies, announced that the US Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) Application for CLN-978 and its global phase 1 clinical trial may ...
Immuneering Corporation’s drug candidate IMM-1-104 receives …
5 days ago · Immuneering Corporation, a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, announced that the US Food and Drug Administration has granted orphan drug designation to IMM-1-104 in the treatment of pancreatic ...
Pfizer’s Hympavzi receives US FDA approval to treat adults and ...
Oct 14, 2024 · Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and paediatric patients 12 years of age and older with haemophilia A (congenital factor VIII ...
US FDA grants Priority Review status Novartis’ Scemblix for …
Jul 31, 2024 · US FDA grants Priority Review status Novartis’ Scemblix for treatment of adults with newly diagnosed CML: East Hanover Wednesday, July 31, 2024, 12:00 Hrs [IST]
Pfizer, BioNTech receive US FDA approval & authorization for …
Saturday, August 24, 2024, 09:00 Hrs [IST] Pfizer Inc. and BioNTech SE announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (Covid-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 ...
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Boehringer Ingelheim’s Cyltezo to treat multiple chronic …
Friday, May 3, 2024, 11:00 Hrs [IST] Boehringer Ingelheim Group, one of the largest producers of biologic medicines in the world, announced that the US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company's interchangeable biosimilar to Humira (adalimumab), to ...