Latest news and insights on the pharmaceutical industry | Indian Pharma Post
Drug Approval
Drug Approval | 17 July 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

Drug Approval
Drug Approval | 17 July 2025

SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally

The receipt of EIR reaffirms the company's commitment to maintaining global quality standards

Drug Approval
Drug Approval | 15 July 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

Drug Approval
Drug Approval | 15 July 2025

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,

Drug Approval
Drug Approval | 15 July 2025

Zydus receives final approval from USFDA for Celecoxib Capsules

Celecoxib is a nonsteroidal anti-inflammatory drug

Drug Approval
Drug Approval | 13 July 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

Drug Approval
Drug Approval | 11 July 2025

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product

Drug Approval
Drug Approval | 11 July 2025

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause

The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials

Drug Approval
Drug Approval | 11 July 2025

FDA accepts new drug application for Merck’s Doravirine/Islatravir

The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act

Drug Approval
Drug Approval | 06 July 2025

Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA

The audit has been concluded with no major observations

Drug Approval
Drug Approval | 02 July 2025

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel

Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery

Drug Approval
Drug Approval | 29 June 2025

Briefs: Neuland Laboratories and Granules India

Granules India receives 1 observation from USFDA for Chantilly facility

Drug Approval
Drug Approval | 29 June 2025

Alembic announces USFDA final approval for single-dose vials

Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma

Drug Approval
Drug Approval | 29 June 2025

Zambon launches intravenous formulation of Fluimucil

The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile

Drug Approval
Drug Approval | 28 June 2025

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME

Drug Approval
Drug Approval | 28 June 2025

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels

Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access

Drug Approval
Drug Approval | 27 June 2025

Biocon Biologics receives Health Canada approval for Yesafili

The approval is based on a comprehensive package of analytical, nonclinical, and clinical data

Drug Approval
Drug Approval | 27 June 2025

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations

Drug Approval
Drug Approval | 27 June 2025

Lupin launches Prucalopride tablets in US

Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA

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