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

FDA nod to first targeted therapy for metastatic pancreatic cancer

The approval covers adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy

Abbott wins FDA authorization for first dual glucose-ketone sensor

Abbott plans to launch the device in the United States later this year

GSK wins first global approval for Hepatitis B therapy bepirovirsen in Japan

The emergence of functional-cure approaches could reshape the market, which has historically been dominated by long-term viral suppression

Japan approves Bayer’s Hyrnuo for HER2-mutant lung cancer

Hyrnuo is the first targeted therapy approved in Japan for this indication that can be used regardless of the line of therapy

Takeda wins Japan approval for Orzeyful to treat narcolepsy type 1

The company is preparing for the launch of Orzeyful in Japan, with the aim of making the treatment available to patients as soon as possible

Govt restricts all Chlorpheniramine-Phenylephrine FDCs for children below four

As per recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB, the use of these combinations may pose risks to children below four years of age

Jubilant Pharmova gets USFDA nod for new isolator-based fill-finish line at Spokane facility

EC approves expanded use of J&J’s Tecvayli with daratumumab in multiple myeloma

The decision by European Commission introduces the teclistamab-daratumumab combination as an earlier treatment option for eligible patients with relapsed or refractory disease