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

FDA moves to boost estradiol patch supply as demand surges

Over the past year, the supply of FDA-approved estradiol transdermal patches has nearly doubled

AstraZeneca breast cancer drug wins US approval after trial cuts progression risk by 56%

The US Food and Drug Administration’s accelerated approval is based on results from the Phase III SERENA-6 trial

Cohance Lifesciences reports conclusion of FDA inspection at Shamshabad facility

The USFDA issued a Form FDA 483 with four observations

Lupin gets US FDA nod for Modafinil tablets

Modafinil is indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder

Ionis wins FDA approval for Zilganersen to treat Alexander disease

The company plans to begin the US commercial rollout in the coming weeks

Sakar Healthcare receives 14 oncology product approvals across EU, UK and Canada

Approvals secured through seven global partners strengthen the company's presence in regulated international markets

Pfizer and BioNTech bag FDA nod for XFG-targeted COVID-19 vaccine

The vaccine is not appropriate for people who have experienced a severe allergic reaction after a previous dose of COMIRNATY