Regulatory
Regulatory | 20 December 2023

FDA grants priority review to Merck’s new biologics license application for V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults

Regulatory
Regulatory | 20 December 2023

Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection

Regulatory
Regulatory | 18 December 2023

Zydus receives USFDA approval USFDA to initiate Phase II clinical trial of ZYIL1 for Parkinson's disease

Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation

Regulatory
Regulatory | 18 December 2023

Lupin receives tentative USFDA approval for Sitagliptin Tablets

Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus

Regulatory
Regulatory | 18 December 2023

Zydus receives final approval from the USFDA for Lacosamide Tablets

Lacosamide is indicated to treat partial-onset seizures

Regulatory
Regulatory | 17 December 2023

Zydus receives final USFDA approval for Cyclophosphamide Capsules USP, 25 mg and 50 mg

Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell

Regulatory
Regulatory | 17 December 2023

Lupin receives USFDA approval for Allopurinol Tablets

The product will be manufactured at Lupin's Pithampur facility in India

Regulatory
Regulatory | 14 December 2023

Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD

Regulatory
Regulatory | 13 December 2023

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting

Regulatory
Regulatory | 12 December 2023

Merck Animal Health receives positive CVMP opinion for an injectable formulation of Bravecto

The CVMP recommends the product for approval for the treatment and persistent killing of fleas

Regulatory
Regulatory | 10 December 2023

Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis

Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections

Regulatory
Regulatory | 09 December 2023

European Commission approves Pfizer’s Elrexfio for multiple myeloma

Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial

Regulatory
Regulatory | 09 December 2023

Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease

Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment

Regulatory
Regulatory | 08 December 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions

Regulatory
Regulatory | 07 December 2023

Zydus receives final approval from the USFDA for methylene blue injection

Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product

Regulatory
Regulatory | 07 December 2023

Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa

Regulatory
Regulatory | 06 December 2023

Granules India received ANDA approval for Sildenafil for oral suspension

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million

Regulatory
Regulatory | 06 December 2023

Zydus receives final approval from the USFDA for Ivabradine Tablets

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States

Regulatory
Regulatory | 04 December 2023

AstraZeneca Pharma India receives permission from CDSCO to import new drug

The receipt of this permission paves way for the launch of BREZTRI AEROSPHERE in India

Regulatory
Regulatory | 02 December 2023

Lupin launches Turqoz (Norgestrel and Ethinyl Estradiol) Tablets in US

Norgestrel and Ethinyl Estradiol Tablets USP (RLD: Lo/Ovral-28) had estimated annual sales of US $33 million in the US

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