FDA

News and Updates by the Food and Drugs Administration (FDA)

AstraZeneca’s Truqap Combo Shows Significant rPFS Improvement in Phase III Trial for PTEN-Deficient mHSPC

Promising outcomes from the CAPItello-281 phase III study reveal that AstraZeneca’s Truqap (capivasertib) alongside abiraterone and androgen deprivation therapy (ADT) yielded a statistically significant and clinically notable enhancement in radiographic progression-free survival (rPFS) compared to abiraterone and ADT with a […]

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DoP Turns Down Neon Labs’ Appeal for Revising Steroid Drug Methylprednisolone’s Price Ceiling

The Department of Pharmaceuticals (DoP) has dismissed a request by Neon Laboratories, based in Mumbai, to re-evaluate the ceiling price determination set by the National Pharmaceutical Pricing Authority (NPPA) for the steroid medication methylprednisolone 40 mg/ml injectable. Neon Laboratories reached

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Professionals Praise Revised Fees and Required GMP Adherence in Updated ASSU Drug Regulations

Industry experts have expressed their approval of the revised fee structure and the enforcement of mandatory Good Manufacturing Practices (GMP) compliance in the newly updated regulations for Ayurvedic, Siddha, Sowa-Rigpa, and Unani (ASSU) medicines. The new fee adaptation for ASSU

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Indian bio-pharma urged to bolster IP resources through progressive research: Dr. Jitendra Kumar

The Indian bio-pharmaceutical industry must allocate resources towards innovative research and development to remain competitive and leverage emerging global market opportunities. Emphasizing the strengthening of intellectual property (IP) assets, Dr. Jitendra Kumar, Managing Director of DBT-BIRAC, stated that prioritizing advanced

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Department of Biotechnology Invites Applications for 2024-25 Research Associateship in Life Sciences

The Department of Biotechnology (DBT) is inviting researchers from leading research institutions, universities, and non-profit R&D organizations across the country to apply for its 2024-25 research associateship in biotechnology and life sciences. The program’s second call has been announced, with

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Smriti College Infuses Pharmaceutical Flair into Traditional Arts During 63rd NPW Celebration in Indore

Smriti College of Pharmaceutical Education in Indore, Madhya Pradesh, marked the 63rd National Pharmacy Week (NPW) with exuberant events spanning November 17 to 23, 2024. The weeklong celebration encompassed a mix of educational, cultural, professional, and athletic activities designed to

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