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1902 News Found

EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1
News | July 27, 2025

EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision


NATCO Pharma API unit in Mekaguda receives EIR from USFDA
Drug Approval | July 24, 2025

NATCO Pharma API unit in Mekaguda receives EIR from USFDA

The company received one observation in the Form-483


Akums launches high-strength Paracetamol oral suspension 500mg/5ml
News | July 23, 2025

Akums launches high-strength Paracetamol oral suspension 500mg/5ml

Akums bridges the long-standing gap between paediatric syrups and conventional tablet formats


Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer
Drug Approval | July 21, 2025

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)


Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
Drug Approval | July 17, 2025

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms


Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL
Drug Approval | July 15, 2025

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL

Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments


Sun Pharma launches LEQSELVI in US for treatment of severe alopecia areata
News | July 14, 2025

Sun Pharma launches LEQSELVI in US for treatment of severe alopecia areata

LEQSELVI now available for prescription in U.S. nationwide, offering a new option for eligible patients


Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’
Drug Approval | July 13, 2025

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease