EC approves Menarini and NewAmsterdam’s obicetrapib therapies

The European Commission approval follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use

India to roll out digital drug regulatory system soon: DCGI

Dr. Rajeev Singh Raghuvanshi outlined next phase of India’s drug regulatory reforms and also revealed plans to create 1,500 new positions to strengthen CDSCO's internal scientific capabilities

FDA approves Lilly’s Inluriyo-Verzenio combination for advanced breast cancer

Patients receiving Inluriyo plus Verzenio had a median progression-free survival of 11.1 months

Zealand Pharma’s Zeydovio gets positive EU recommendation for short bowel syndrome

The recommendation marks a significant step toward potential approval of the therapy across the European Union

Biocon's Pertuzumab wins historic EMA CHMP nod under new tailored clinical pathway

The CHMP has advised granting marketing authorisation for the drug as a 420 mg concentrate solution for infusion

AstraZeneca’s HPP drug candidate wins FDA priority review

If approved, efzimfotase alfa would be the first treatment intended to address both skeletal abnormalities and functional impairments across patients with HPP

Novo gets positive EU recommendation for weekly growth hormone treatment in children with short stature

The CHMP recommendation is based on data from the REAL8 clinical trial

Merck’s Keytruda-Padcev combo clears key EU regulatory hurdle in bladder cancer

The European Commission will now review the recommendation, with a final decision expected in the fourth quarter of 2026

Bayer’s Kerendia wins FDA nod for chronic kidney disease linked to Type 1 diabetes

The approval for Kerendia (finerenone), a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), covers finerenone at 10mg and 20mg doses

USFDA closes inspection at Alembic Pharma’s Vadodara bioequivalence facility

The regulator has issued Establishment Inspection report following inspection conducted in March 2025

FDA reduces initial monitoring time for Amgen’s Imdelltra

The revised prescribing information cuts post-infusion observation from 22–24 hours to six–eight hours for the first two doses to adults with extensive-stage small cell lung cancer

FDA cuts monitoring time for first two doses of Amgen’s IMDELLTRA

Patients will also undergo a follow-up assessment, including vital signs, the day after each of those initial doses

Godavari Biorefineries receives Chinese patent approval for viral infection treatment compounds

The patent, titled “Use of Compounds for Treating Viral Infections,” covers compounds that inhibit V-ATPase activity in cells

Aurobindo Pharma receives final USFDA approval for generic Beclomethasone inhalation Aerosol

Aurobindo Pharma's first metered-dose inhaler marks a major step into complex respiratory treatments

USFDA classifies Jubilant Pharmova's Spokane CMO Facility as VAI

The VAI classification signifies that objectionable conditions or practices were observed during the inspection

USFDA issues Form 483 with three observations to Strides Pharma's Alathur facility

The regulatory body carried out a routine current Good Manufacturing Practices inspection at the company's formulations facility located in Alathur, Chennai

Roche’s Enspryng gets FDA Priority Review for MOGAD treatment

The FDA’s action follows positive Phase III METEOROID trial results

Indoco Remedies’ Goa plant clears UKMHRA inspection without major observations

Shilpa Medicare gets final nod for novel 5-day anti-nausea injection

The company said OERIS is designed to be the world’s first extended-release ondansetron injectable formulation

FDA grants accelerated approval to sevabertinib for first-line HER2-mutated NSCLC

The FDA’s decision is based on objective response rate (ORR) and duration of response (DOR) data from 69 treatment-naïve patients enrolled in the ongoing Phase I/II SOHO-01 trial