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Biocon Launches Denosumab Biosimilars in U.S. to Address Bone Health Needs

Biocon Launches Denosumab Biosimilars in U.S. to Address Bone Health Needs

Biocon Launches Denosumab Biosimilars in U.S. to Address Bone Health Needs
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Biocon Launches Denosumab Biosimilars in U.S. to Address Osteoporosis and Cancer-Related Bone Issues

Biocon Launches Denosumab Biosimilars in U.S. to Address Osteoporosis and Cancer-Related Bone Issues

Biocon Launches Denosumab Biosimilars in U.S. to Address Osteoporosis and Cancer-Related Bone Issues
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Upsher-Smith Launches Generic Version of Ciprodex to Expand Generics Portfolio

Upsher-Smith Launches Generic Version of Ciprodex to Expand Generics Portfolio

Upsher-Smith Launches Generic Version of Ciprodex to Expand Generics Portfolio
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Upsher-Smith Launches Generic Ciprodex to Address Drug Market Needs

Upsher-Smith Launches Generic Ciprodex to Address Drug Market Needs

Upsher-Smith Launches Generic Ciprodex to Address Drug Market Needs
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NanoViricides Files for Rare Pediatric Disease Drug Designation for Measles Treatment NV-387

NanoViricides Files for Rare Pediatric Disease Drug Designation for Measles Treatment NV-387

NanoViricides Files for Rare Pediatric Disease Drug Designation for Measles Treatment NV-387
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Vyome to Present Phase 2 Clinical Data on VT-1953 for Malignant Fungating Wounds at AACR 2026

Vyome to Present Phase 2 Clinical Data on VT-1953 for Malignant Fungating Wounds at AACR 2026

Vyome to Present Phase 2 Clinical Data on VT-1953 for Malignant Fungating Wounds at AACR 2026
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FDA Declines Guidance on Foreign Drug Imports Amid Regulatory Concerns

FDA Declines Guidance on Foreign Drug Imports Amid Regulatory Concerns

The FDA has declined to issue specific guidance on the importation of foreign drugs by alternative funding programs (AFPs), despite concerns about the legality and safety of these practices. AFPs connect patients with affordable versions of expensive medications from foreign markets, potentially violating U.S. import laws. The FDA acknowledged the risks of contaminated or counterfeit drugs but stated that issuing guidance is not warranted at this time. The decision leaves a regulatory grey area, impacting patient advocacy groups seeking clarity on the legality of AFP practices.
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AIRNA Begins Phase 1 Trial of RNA-Editing Therapy for Genetic Lung Disease

AIRNA Begins Phase 1 Trial of RNA-Editing Therapy for Genetic Lung Disease

AIRNA Begins Phase 1 Trial of RNA-Editing Therapy for Genetic Lung Disease
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FDA's 2027 Budget Proposes Permanent Rare Disease Vouchers and Regulatory Reforms

FDA's 2027 Budget Proposes Permanent Rare Disease Vouchers and Regulatory Reforms

The FDA's proposed budget for 2027 includes a $7.23 billion allocation, marking a 3.2% increase from the previous year. This budget aims to transition the FDA from a reactionary to a proactive regulatory system, with reforms such as making the rare pediatric disease priority review voucher program permanent. The budget also proposes a new clinical trial notification pathway to simplify the process for launching Phase 1 trials in the U.S. These initiatives are designed to expedite drug development, enhance national security, and promote transparency, while addressing regulatory burdens that have driven companies to conduct early-stage studies abroad.
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Vyome to Present Phase 2 Clinical Data on VT-1953 for MFW Treatment at AACR 2026

Vyome to Present Phase 2 Clinical Data on VT-1953 for MFW Treatment at AACR 2026

Vyome to Present Phase 2 Clinical Data on VT-1953 for MFW Treatment at AACR 2026
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States Extend RSV Immunization Period Amid Continued Spread

States Extend RSV Immunization Period Amid Continued Spread

The spread of respiratory syncytial virus (RSV) has prompted most U.S. states to extend the immunization period for infants and toddlers through April. RSV typically peaks in winter, but this year, the virus is persisting into spring, leading to increased hospitalizations among young children. Monoclonal antibodies, which provide passive immunity, are being administered to reduce hospitalization rates. Dr. Susan Kansagra from the Association of State and Territorial Health Officials emphasizes the importance of this extension, as RSV remains a leading cause of infant hospitalization.
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Rosen Law Firm Urges Corcept Therapeutics Investors to Act Before Class Action Deadline

Rosen Law Firm Urges Corcept Therapeutics Investors to Act Before Class Action Deadline

Rosen Law Firm Urges Corcept Therapeutics Investors to Act Before Class Action Deadline