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Latest Industry News - Page 383

USFDA grants priority review to Sanofi-Regeneron Dupixent for bullous pemphigoid

Sanofi terminates deal to exclusively license Maze Therapeutics Pompe disease drug

Ruchika Sharma12 Dec 2023 2:30 PM IST
Washington: Sanofi has said it was terminating a deal to exclusively license a drug that Maze Therapeutics is developing to treat Pompe disease...
Solara Active Pharma Sciences Mangalore facility successfully completes USFDA inspection

Torrent Pharma gets 5 USFDA observations for Gujarat facility

Ruchika Sharma12 Dec 2023 1:06 PM IST
Ahmedabad: Torrent Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded the inspection with 5 procedural...
USFDA updates Camzyos label to reduce echocardiography monitoring requirements, contraindications: Bristol Myers Squibb

Bristol Myers Squibb, SystImmune collaborate for development, commercialization of BL-B01D1

Ruchika Sharma12 Dec 2023 12:30 PM IST
Princeton: SystImmune, a clinical-stage biopharmaceutical company, and Bristol Myers Squibb have announced an exclusive license and collaboration...
USFDA nod to Padcev plus Keytruda for certain patients with Bladder cancer: Pfizer, Astellas Pharma

Pfizer Marstacimab regulatory submissions for treatment of Hemophilia A and B accepted by USFDA, EMA

Ruchika Sharma12 Dec 2023 11:28 AM IST
The submissions for marstacimab are based on efficacy and safety data from the Phase 3 BASIS trial.
Cipla US arm recalls Vigabatrin for Oral Solution, USP 500mg over pouch leakage issues

Cipla US arm recalls Vigabatrin for Oral Solution, USP 500mg over pouch leakage issues

Ruchika Sharma11 Dec 2023 3:00 PM IST
Cipla has not received any reports of adverse events related to this recall.
Sanofi Sarclisa approved in EU

Sarclisa plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone: Sanofi

Ruchika Sharma11 Dec 2023 2:30 PM IST
Paris: Sanofi has announced that the Phase 3 trial investigating Sarclisa (isatuximab) in combination with carfilzomib, lenalidomide and...
Lupin Partners with TB Alliance to Advance Telacebec for TB, Leprosy and Buruli Ulcer

Zydus, Daewoong Pharma collaborate to co-develop, commercialise Leuprolide Long-Acting Injectable in US

Ruchika Sharma11 Dec 2023 12:30 PM IST
Leuprolide acetate for depot suspension is a gonadotropin-releasing hormone (GnRH) agonist, a long-acting injectable product in a kit with a prefilled...
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

Intas Pharma gets USFDA warning letter due to manufacturing lapses at Ahmedabad plant

Ruchika Sharma11 Dec 2023 11:30 AM IST
"Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," USFDA said.
Merck gets USFDA Priority Review for application for Keytruda plus standard of care as Perioperative treatment for Resectable Locally Advanced Head, Neck Squamous Cell Carcinoma

Merck announces positive results from phase 2 trial evaluating coformulation of vibostolimab, pembrolizumab in lung cancer patients

Ruchika Sharma10 Dec 2023 2:00 PM IST
Rahway: Merck, known as MSD outside of the United States and Canada, has announced full results from the non-registrational Phase 2 KeyVibe-002...
Novo Nordisk Wegovy approved by USFDA for adults with noncirrhotic MASH with liver fibrosis

Ozempic side effects lawsuit can move forward

Ruchika Sharma10 Dec 2023 12:30 PM IST
A Louisiana federal judge on Friday largely rejected Novo Nordisk’s bid to dismiss one of the earliest lawsuits brought against the pharmaceutical...
Sanofi gets approval for 2 rare hematologic diseases medicines in China

Sanofi multiple myeloma drug Sarclisa phase 3 trial meets primary endpoint of progression-free survival

Ruchika Sharma10 Dec 2023 11:30 AM IST
Paris: Sanofi has announced that the Phase 3 IMROZ trial evaluating the investigational use of Sarclisa (isatuximab) in combination with...
Lupin Partners with TB Alliance to Advance Telacebec for TB, Leprosy and Buruli Ulcer

Bayer, Salus Optima collaborate on AI-Enabled Healthy Aging Journey

Ruchika Sharma10 Dec 2023 10:00 AM IST
London: Salus Optima, a provider of AI-enabled digital health and wellness solutions, and the Consumer Health division of Bayer have launched a...
PrevNext

Editorial

ROBUST Study Released: One of the Largest Beta-Blocker KAP Study Captures Place of Beta Blockers in Indian Real-World Practice

ROBUST Study Released: One of the Largest Beta-Blocker KAP Study Captures Place of Beta Blockers in...

Obesity-Prediabetes Duo: Why Clinicians Must Intervene Early?

Obesity-Prediabetes Duo: Why Clinicians Must Intervene Early?

SURPASS-2- Tirzepatide vs Semaglutide in Type 2 Diabetes

SURPASS-2- Tirzepatide vs Semaglutide in Type 2 Diabetes

Efficacy and Safety of Dapagliflozin-Vildagliptin in Indian T2DM Patients with CV Risk Factors

Efficacy and Safety of Dapagliflozin-Vildagliptin in Indian T2DM Patients with CV Risk Factors

SURPASS-2: Superior HbA1c and Weight Reduction With Tirzepatide vs. Semaglutide

SURPASS-2: Superior HbA1c and Weight Reduction With Tirzepatide vs. Semaglutide

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Journal Club Today

MRI Study Maps Brain Growth Across the Perinatal Period

MRI Study Maps Brain Growth Across the Perinatal Period

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Health News Today

Health Bulletin 07/February/2026

Health Bulletin 07/February/2026

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